Diphenhydramine (Systemic)

Introductory Information
First generation antihistamine; an ethanolamine-derivative.a
Class: 4:04 First Generation Antihistamines; ah200 (VA primary); re599 (VA primary)
Brands*: Alka-Seltzer PM, AllerMax, Bayer PM, Benadryl, Benadryl Allergy, Compoz,
Diphenhist, Doan's P.M., Excedrin P.M., Genahist, Goody's PM Powder, Hydramine,
Legatrin PM, Nighttime Sleep Aid, Nytol, Percogesic, Simply Sleep, Sine-Off,
Sleepinal, Sominex, Sudafed, Tylenol Allergy, Tylenol PM, Twilite, Unisom
*

also available generically

Generic Name: Diphenhydramine Citrate

CAS Number: 88637-37-0
Generic Name: Diphenhydramine Hydrochloride
CAS Number: 147-24-0
Generic Name: Acetaminophen and Diphenhydramine Citrate
Synonym: Diphenhydramine Citrate and Acetaminophen
Special Alerts:
[Posted 01/13/2011] ISSUE: FDA notified healthcare professionals that it has asked drug
manufacturers to limit the strength of acetaminophen in prescription drug products,
predominantly combinations of acetaminophen and opioids, to 325 mg per tablet, capsule, or
other dosage unit, making these products safer for patients. This action will help to reduce
the risk of severe liver injury and allergic reactions associated with acetaminophen. A Boxed
Warning highlighting the potential for severe liver injury and a Warning highlighting the
potential for allergic reactions (swelling of the face, mouth, and throat, difficulty breathing,
itching, or rash) will be added to the label of all prescription drug products that contain
acetaminophen.
BACKGROUND: Acetaminophen, one of the most commonly used drugs in the United
States, is widely and effectively used in both prescription and over-the-counter (OTC)
products to reduce pain and fever. Examples of prescription products that contain
acetaminophen include hydrocodone with acetaminophen (Vicodin, Lortab), and oxycodone
with acetaminophen (Tylox, Percocet). OTC products containing acetaminophen (e.g.,
Tylenol) are not affected by this action. Information about the potential for liver injury is
already required on the label for OTC products containing acetaminophen. FDA is continuing
to evaluate ways to reduce the risk of acetaminophen related liver injury from OTC products.
No drug shortages are expected, because the 3-year implementation period should permit
adequate time for necessary reformulations.
RECOMMENDATION: Healthcare professionals were reminded to advise patients not to
exceed the acetaminophen maximum total daily dose (4 grams/day), and not to drink alcohol
while taking acetaminophen-containing medications.

Healthcare professionals were encouraged to inform patients that there is no immediate

danger to patients who take these combination pain medications, and patients should
continue to take them as directed by their health care provider. The Drug Safety
Communication provides additional information for healthcare professionals, information for
patients, a data summary and a list of all affected products. For more information visit the
FDA website at: [Web] and [Web].
Uses
Acute Allergic Reactions
Amelioration of allergic reactions to blood or plasma.101
Adjunct to epinephrine and other standard measures for management of anaphylaxis after
acute symptoms have been controlled.101, 102, 103
Used IV or IM for management of other uncomplicated allergic conditions of the immediate
type when oral therapy is impossible or contraindicated.101
Allergic Rhinitis
Self-medication for temporary relief of rhinorrhea, sneezing, lacrimation, itching eyes,
oronasopharyngeal irritation or itching, or cough associated with allergic rhinitis (e.g., hay
fever) or other upper respiratory allergies.
Used in fixed combination with other agents (e.g., acetaminophen, phenylephrine,
pseudoephedrine) for relief of rhinorrhea, sneezing, lacrimation, itching eyes,
oronasopharyngeal itching, and/or other symptoms (e.g., headache, nasal/sinus congestion)
associated with seasonal or perennial allergic rhinitis or other upper respiratory allergies.110,
112, 114

Use fixed-combination preparations only when symptoms amenable to each ingredient are
present concurrently.
Common Cold
Self-medication for temporary relief of symptoms associated with the common cold (e.g.,
rhinorrhea, sneezing, cough).
Used in fixed combination with other agents (e.g., acetaminophen, phenylephrine,
pseudoephedrine) for symptomatic relief of rhinorrhea, sneezing, and/or other symptoms
associated with the common cold (e.g., headache, minor aches and pains, sore throat, cough,
nasal congestion).108, 112, 114
Insomnia
Self-medication for short-term (i.e., 2 weeks) management of occasional sleeplessness,
particularly in individuals who have difficulty falling asleep.104
Used in fixed combination with other agents (e.g., acetaminophen, aspirin) for short-term
management of occasional sleeplessness.107, 109, 111, 113

Development of tolerance reported with repeated use.104

Dermatologic Disorders
Systemic antihistamines may be more effective than topical, especially if pruritus is
generalized, and less likely to cause sensitivity reactions than when applied topically for
pruritus associated with various dermatologic conditions.
Motion Sickness
Prevention and treatment of nausea, vomiting, and/or vertigo associated with motion
sickness.101
Parkinsonian Syndrome
May be useful as alternative therapy in the management of tremor early in the course of
parkinsonian syndrome. Also may be useful in the management of drug-induced
extrapyramidal reactions.
Used IV for management of parkinsonian syndrome when oral therapy is impossible or
contraindicated.101 Used specifically in geriatric patients who are unable to tolerate more
potent agents; for mild cases of parkinsonism in younger patients; and in combination with
centrally acting anticholinergic agents in other cases of parkinsonism.101
Dosage and Administration
Administration
Administer diphenhydramine hydrochloride orally or by IV or deep IM injection.a
Administer diphenhydramine citrate-containing preparations orally.a
Oral Administration
Diphenhydramine hydrochloride chewable tablets: Chew thoroughly before swallowing.a
Diphenhydramine citrate orally disintegrating tablets: Place tablet on the tongue, allow tablet
to disintegrate (within a few seconds), then swallow with or without water.a
IV Administration
For solution and drug compatibility information, see Compatibility under Stability.
IV injection preferred over deep IM injection.a
IV use in a home-care setting should be employed under careful supervision.a
Rate of Administration
25 mg/minute.
Dosage
Available as diphenhydramine hydrochloride and diphenhydramine citrate; dosage is
expressed in terms of diphenhydramine hydrochloride or diphenhydramine citrate.a

Diphenhydramine citrate available only in fixed-combination preparations.a

12.5 mg diphenhydramine hydrochloride equivalent to 19 mg diphenhydramine citrate.a
Fixed-combination preparations do not permit individual titration of dosages. When used in
fixed combination with other agents (e.g., acetaminophen, aspirin, phenylephrine,
pseudoephedrine), select a dosage that is within the usual therapeutic range for each
ingredient. Because combinations and dosage strengths vary for fixed-combination
preparations, consult manufacturer's product labeling for appropriate dosage of the specific
preparation.
Pediatric Patients
Allergic Conditions and the Common Cold
>Acute Allergic Reactions
IV or IM: Children >1 month of age: 5 mg/kg daily or 150 mg/m2 daily (up to a maximum of
300 mg daily) divided in 4 doses.
Alternatively, 1-2 mg/kg recommended by some experts.102, 103
>Allergic Rhinitis and the Common Cold
Oral: Self-medication in children 2-5 years of age: 6.25 mg every 4-6 hours (as
diphenhydramine hydrochloride) or 9.5 mg every 4 hours (as diphenhydramine citrate) when
directed by a clinician; do not exceed 37.5 mg (as diphenhydramine hydrochloride) or 57 mg
(as diphenhydramine citrate) in 24 hours. (See Pediatric Use under Cautions.)
Self-medication in children 6-11 years of age: 12.5-25 mg every 4-6 hours (as
diphenhydramine hydrochloride) or 19 mg every 4 hours (as diphenhydramine citrate); do not
exceed 150 mg (as diphenhydramine hydrochloride) or 76 mg (as diphenhydramine citrate) in
24 hours.
Self-medication in children 12 years of age: 25-50 mg every 4-6 hours (as diphenhydramine
hydrochloride) or 38 mg every 4 hours (as diphenhydramine citrate); do not exceed 300 mg
(as diphenhydramine hydrochloride) or 152 mg (as diphenhydramine citrate) in 24 hours.
Insomnia
Oral: Children 2-11 years of age

: 1 mg/kg (as diphenhydramine hydrochloride) 30

minutes before retiring; do not exceed 50 mg.

Self-medication in children 12 years of age: 50 mg (as diphenhydramine hydrochloride) or
76 mg (as diphenhydramine citrate) at bedtime as needed, or as directed by a clinician.
Higher dosages do not produce substantially greater benefit but may be associated with a
higher incidence of adverse (e.g., anticholinergic) effects.
Use not recommended for 7-10 nights.104
Motion Sickness
Oral: Children 2-5 years of age

: 6.25 mg (as diphenhydramine hydrochloride) 30-60

minutes before travel and every 4-6 hours during travel; do not exceed 37.5 mg in 24 hours.105
Self-medication in children 6-11 years of age: 12.5-25 mg (as diphenhydramine
hydrochloride) 30-60 minutes before travel and every 4-6 hours during travel; do not exceed
150 mg in 24 hours.105

Self-medication in children 12 years of age: 25-50 mg (as diphenhydramine hydrochloride)

30 minutes before exposure to motion and then every 4-6 hours (before meals and at bedtime)
for duration of exposure; do not exceed 300 mg in 24 hours.
>IV or IM
Children >1 month of age: 5 mg/kg daily or 150 mg/m2 daily (up to a maximum of 300 mg
daily) divided in 4 doses.
Parkinsonian Syndrome
>IV or IM
Children >1 month of age: 5 mg/kg daily or 150 mg/m2 daily (up to a maximum of 300 mg
daily) divided in 4 doses.
Adults
Allergic Conditions and the Common Cold
>Acute Allergic Reactions
IV or IM: 10-50 mg; in a few patients, up to 100 mg may be required.
Alternatively, 25-50 mg recommended by some experts.102, 103
>Allergic Rhinitis and the Common Cold
Oral: Self-medication: 25-50 mg every 4-6 hours (as diphenhydramine hydrochloride) or 38
mg every 4 hours (as diphenhydramine citrate); do not exceed 300 mg (as diphenhydramine
hydrochloride) or 152 mg (as diphenhydramine citrate) in 24 hours.
Insomnia
Oral: Self-medication: 50 mg (as diphenhydramine hydrochloride) or 76 mg (as
diphenhydramine citrate) at bedtime as needed, or as directed by a clinician. Higher dosages
do not produce substantially greater benefit but may be associated with a higher incidence of
adverse (e.g., anticholinergic) effects.
Use not recommended for 7-10 nights.104
Motion Sickness
Oral: Self-medication: 25-50 mg (as diphenhydramine hydrochloride) 30 minutes before
exposure to motion and then every 4-6 hours (before meals and at bedtime) for duration of
exposure; do not exceed 300 mg in 24 hours.
>IV or IM
10-50 mg; in a few patients, up to 100 mg may be required.
Parkinsonian Syndrome
Oral: Initially, 25 mg 3 times daily (as diphenhydramine hydrochloride).a If necessary,
gradually increase dosage to 50 mg 4 times daily.a
>IV or IM
10-50 mg; in a few patients, up to 100 mg may be required.
Prescribing Limits
Pediatric Patients
Oral
Children 2-5 years of age: Maximum 37.5 mg (as diphenhydramine hydrochloride) or 57 mg
(as diphenhydramine citrate) in 24 hours. (See Pediatric Use under Cautions.)

Children 6-11 years of age: Maximum 150 mg (as diphenhydramine hydrochloride) or 76 mg

(as diphenhydramine citrate) in 24 hours.
Children 12 years of age: Maximum 300 mg (as diphenhydramine hydrochloride) or 152 mg
(as diphenhydramine citrate) in 24 hours.
IV or IM
Children >1 month: Maximum 300 mg daily.101
Adults
Oral
Maximum 300 mg in 24 hours.
IV or IM
Maximum 400 mg daily.101
Cautions
Contraindications
Use contraindicated in neonates and premature infants.101 (See Pediatric Use under Cautions.)
Women who are breast-feeding.101 (See Lactation under Cautions.)
Injection should not be used as a local anesthetic.101 (See Local Necrosis under Cautions.)
Concomitant use with other preparations containing diphenhydramine, including oral and
topical preparations.
Known hypersensitivity to diphenhydramine, other antihistamines with similar chemical
structure, or any ingredient in the formulation.
Warnings/Precautions
Warnings
Concomitant Diseases
Patients with glaucoma, respiratory conditions (e.g., emphysema, chronic bronchitis), or
difficulty urinating due to prostatic hypertrophy should consult a clinician before initiating
therapy with diphenhydramine.
Use with caution in patients with increased IOP, angle-closure glaucoma, stenosing peptic
ulcer, pyloroduodenal obstruction, bladder-neck obstruction, symptomatic prostatic
hypertrophy, active or a history of lower respiratory disease (e.g., bronchial asthma),
hyperthyroidism, or cardiovascular disease (e.g., hypertension).
CNS Effects
Risk of marked drowsiness. Among first generation antihistamines, ethanolamines (e.g.,
diphenhydramine) considered the most sedating106, c and alkylamines (e.g., brompheniramine,
chlorpheniramine) considered the least sedating.106
Possible excitability (especially in children).
Caution when driving a motor vehicle, operating machinery, or engaging in other potentially
hazardous tasks.c (See CNS Depressants under Interactions.)
Diphenhydramine Toxicity

Risk of toxicity. (See Pediatric Use under Cautions.) Do not use more often than directed for
any condition; do not concomitantly use more than one preparation containing
diphenhydramine (e.g., avoid simultaneous use of oral and topical preparations).
Local Necrosis
Risk of local necrosis with subcutaneous or intradermal administration. Do not use
diphenhydramine injection as a local anesthetic.
Sensitivity Reactions
Sulfite Sensitivity
Some formulations may contain sulfites, which may cause allergic-type reactions (including
anaphylaxis and life-threatening or less severe asthmatic episodes) in certain susceptible
individuals.a
General Precautions
Duration of Therapy
When used for insomnia, avoid using for self-medication for longer than 7-10 nights,104 and
consult a clinician if insomnia persists continuously for >2 weeks.
Phenylketonuria
Certain preparations (e.g., Alka-Seltzer PM, Benadryl chewable tablets; Children's
Benadryl Allergy & Sinus Fastmelt orally disintegrating tablets) contain aspartame
(NutraSweet) which is metabolized in the GI tract to phenylalanine following oral
administration.113, 114, a
Use of Fixed Combinations
Pending revision, the material in this section should be considered in light of more recently
available information in the MEDWATCH notification at the beginning of this monograph.
When used in fixed combination with other agents (e.g., acetaminophen, aspirin,
phenylephrine, pseudoephedrine), consider the cautions, precautions, and contraindications
associated with the concomitant agent(s).107, 108, 109, 110, 111, 112, 113, 114
Specific Populations
Pregnancy
Category B.
Lactation
Has been detected in milk. Discontinue nursing or the drug because of potential risk to
nursing infants.
Pediatric Use
Risk of diminished mental alertness. Risk of excitation in young pediatric patients.
Risk of diphenhydramine toxicity (e.g., dilated pupils, flushed face, hallucinations, ataxic
gait, urinary retention) when oral preparations used concomitantly with topical preparations
of diphenhydramine. (See Diphenhydramine Toxicity under Cautions.)
Potential for misuse and abuse following parenteral administration over a prolonged period of
time.

Use with caution in infants and young children; should not be used in premature or full-term
neonates. Children <6 years of age should receive oral diphenhydramine only under the
direction of a physician.
Safety and efficacy of diphenhydramine as a nighttime sleep aid in children <12 years of age
have not been established. Consider risk of possible CNS stimulation when used as nighttime
sleep aids.
Risk of overdosage and toxicity (including death) in children <2 years of age receiving OTC
preparations containing antihistamines, cough suppressants, expectorants, and nasal
decongestants alone or in combination for relief of symptoms of upper respiratory tract
infection. Limited evidence of efficacy for these preparations in this age group; appropriate
dosages not established. Therefore, FDA recommended not to use such preparations in
children <2 years of age; safety and efficacy in older children currently under evaluation.
Because children 2-3 years of age also are at increased risk of overdosage and toxicity, some
manufacturers of oral nonprescription cough and cold preparations recently agreed to
voluntarily revise the product labeling to state that such preparations should not be used in
children <4 years of age. During the transition period, some preparations on pharmacy
shelves will have the new recommendation ("do not use in children <4 years of age"), while
others will have the previous recommendation ("do not use in children <2 years of age").
FDA recommends that parents and caregivers adhere to dosage instructions and warnings on
the product labeling that accompanies the preparation and consult a clinician about any
concerns. Clinicians should ask caregivers about use of OTC cough/cold preparations to
avoid overdosage.
Geriatric Use
Possible increased risk of dizziness, sedation, and hypotension in patients 60 years of age.
Common Adverse Effects
Sedation, sleepiness, dizziness, disturbed coordination, epigastric distress, thickening of
bronchial secretions.
Interactions
CNS Depressants
Potential pharmacologic interaction (additive CNS depression) with alcohol and other CNS
depressants (e.g., hypnotics, sedatives, tranquilizers).
Laboratory Test Interferences
Antihistamines may suppress inhalation-challenge testing with histamine or antigen as well
as the wheal and flare reactions to antigen skin testing.
Specific Drugs
Drug

Interaction
MAO inhibitors prolong and intensify anticholinergic effects of
MAO inhibitors
antihistamines

Pharmacokinetics
Absorption
Bioavailability
Well absorbed following oral administration, but only about 40-60% of an oral dose reaches
systemic circulation as unchanged drug.
Onset
Appears in plasma within 15 minutes following oral administration of a single dose; peak
plasma concentrations are attained within 1-4 hours.
Antihistamine effect peaks within 1-3 hours and persists for up to 7 hours after administration
of a single dose.
Sedative effects peak within 1-3 hours after administration of a single dose.
Distribution
Extent
Highest concentrations detected in the lungs, spleen, and brain in rats; small amounts
detected in the heart, muscle, and liver.
Crosses the placenta and has been detected in milk, although the extent of distribution into
milk has not been quantitated.
Plasma Protein Binding
Approximately 80-85%.
Special Populations
Larger volume of distribution in Asian adults (about 480 L) than in white adults (188-336 L).
Less extensive protein binding reported in healthy Asian adults and in adults with liver
cirrhosis.
Elimination
Metabolism
Rapidly and apparently almost completely metabolized.
Undergoes substantial first-pass metabolism in the liver following oral administration.
Elimination Route
Excreted in urine (50-75%) mainly as metabolites.
Half-Life
2.4-9.3 hours in healthy adults.
Special Populations
Terminal elimination half-life is prolonged in adults with liver cirrhosis.
Stability

Storage
Oral
Capsules and Tablets
15-25C. Protect from heat, light, and moisture.
Parenteral
Injection
15-30C. Protect from freezing and light.
Compatibility
For information on systemic interactions resulting from concomitant use, see Interactions.
Parenteral
Solution CompatibilityHID
Compatible
Dextran 6% in dextrose 5%
Dextran 6% in sodium chloride 0.9%
Dextrose-Ringer's injection combinations
Dextrose-Ringer's injection, lactated, combinations
Dextrose-saline combinations
Dextrose 2.5, 5, or 10% in water
Fat emulsion 10%, intravenous
Fructose 10% in sodium chloride 0.9%
Fructose 10% in water
Invert sugar 5 and 10% in sodium chloride 0.9%
Invert sugar 5 and 10% in water
Ionosol products
Ringer's injection
Ringer's injection, lactated
Sodium chloride 0.45 or 0.9%
Sodium lactate (1/6) M
>Drug Compatibility
>Admixture CompatibilityHID
Compatible
Amikacin sulfate
Aminophylline
Ascorbic acid injection
Bleomycin sulfate
Colistimethate sodium
Erythromycin lactobionate
Hydrocortisone sodium succinate
Lidocaine HCl
Methyldopate HCl

Nafcillin sodium
Penicillin G potassium
Penicillin G sodium
Polymyxin B sulfate
Vitamin B complex with C
Incompatible
Amobarbital sodium
Amphotericin B
Dexamethasone sodium phosphate with lorazepam and metoclopramide HCl
Iodipamide meglumine (% unspecified)
Thiopental sodium
>Y-Site CompatibilityHID
Compatible
Abciximab
Acyclovir sodium
Aldesleukin
Amifostine
Amsacrine
Argatroban
Azithromycin
Aztreonam
Bivalirudin
Ciprofloxacin
Cisplatin
Cladribine
Cyclophosphamide
Cytarabine
Dexmedetomidine HCl
Docetaxel
Doxorubicin HCl
Doxorubicin HCl liposome injection
Etoposide phosphate
Famotidine
Fenoldopam mesylate
Fentanyl citrate
Filgrastim
Fluconazole
Fludarabine phosphate
Gallium nitrate
Gemcitabine HCl
Granisetron HCl
Heparin sodium
Hetastarch in lactated electrolyte injection (Hextend)
Hydrocortisone sodium succinate

Hydromorphone HCl
Idarubicin HCl
Linezolid
Melphalan HCl
Meperidine HCl
Meropenem
Methadone HCl
Methotrexate sodium
Morphine sulfate
Ondansetron HCl
Oxaliplatin
Paclitaxel
Pemetrexed disodium
Piperacillin sodium-tazobactam sodium
Potassium chloride
Propofol
Remifentanil HCl
Sargramostim
Sufentanil citrate
Tacrolimus
Teniposide
Thiotepa
Vinorelbine tartrate
Vitamin B complex with C
Incompatible
Allopurinol sodium
Amphotericin B cholesteryl sulfate complex
Cefepime HCl
Foscarnet sodium
Lansoprazole
Actions
Blocks H1-receptor sites, thereby preventing the action of histamine on the cell.c
Suppresses flare and pruritus that accompany the endogenous release of histamine.c
Exhibits some activities common to anticholinergics, ganglionic and adrenergic blocking
agents, local anesthetics, and antispasmodics.c
Antihistamines do not block the stimulating effect of histamine on gastric acid secretion,
which is mediated by H2-receptors of the parietal cells.c
Effects on parkinsonian syndrome and drug-induced extrapyramidal reactions are apparently
related to central anticholinergic effects.c
Advice to Patients
Pending revision, the material in this section should be considered in light of more recently
available information in the MEDWATCH notification at the beginning of this monograph.

 Risk of drowsiness; avoid alcohol and use caution when driving, operating machinery, or
engaging in other hazardous tasks.
When used for insomnia, consult a clinician if sleeplessness persists continuously for >2
weeks.
Importance of informing clinicians of existing or contemplated therapy, including prescription
and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses.
Importance of patients already receiving another CNS depressant (e.g., sedatives,
tranquilizers) not undertaking self-medication without first consulting a clinician.
Importance of not using multiple diphenhydramine-containing preparations (either oral or
topical) simultaneously because of risk of toxicity. (See Diphenhydramine Toxicity under
Cautions.)
Importance of women informing their clinician if they are or plan to become pregnant or plan
to breast-feed.
Importance of informing patients of other important precautionary information. (See
Cautions.)
Preparations
Excipients in commercially available drug preparations may have clinically important effects
in some individuals; consult specific product labeling for details.
Pending revision, the material in this section should be considered in light of more recently
available information in the MEDWATCH notification at the beginning of this monograph.
In response to concerns regarding the safety and efficacy of cough and cold preparations in
young children, many nonprescription cough and cold preparations specifically formulated
for infants have been voluntarily withdrawn from the US market. Therefore, some of the
preparations described below may no longer be commercially available in the US.
Diphenhydramine Hydrochloride
Routes
Dosage Forms Strengths
Oral
Capsules
25 mg*

50 mg*
Capsules,
liquid-filled

25 mg
50 mg

Elixir

12.5 mg/5
mL*

Brand Names
Benadryl Allergy Kapseals
Diphenhist
Diphenhydramine
Hydrochloride Capsules
Genahist
Diphenhydramine
Hydrochloride Capsules
Benadryl Dye-Free Allergy
Liqui-Gels
Nytol Quickgels Maximum
Strength
Sleepinal Night-time Sleep
Aid Softgels
Unisom SleepGels
Maximum Strength

Manufacturer
Pfizer
Rugby

Diphen AF Elixir

Morton Grove

Teva

Pfizer
Block
Blairex
Pfizer

Diphenhydramine
Hydrochloride Elixir
Genahist Elixir
Hydramine Elixir
Solution

Tablets

12.5 mg/5
mL*

25 mg*

50 mg

Tablets,
chewable
Tablets, filmcoated

12.5 mg
25 mg

Teva
Alpharma, Moore,
Teva

AllerMax

Pfeiffer

Benadryl Allergy
Benadryl Dye-Free Allergy
Children's
Diphenhist
Diphenhydramine Solution
Hydramine Cough Syrup
Diphenhist Captabs
Diphenhydramine
Hydrochloride Tablets
Genahist
Miles Nervine Nighttime
Sleep-Aid
Nytol QuickCaps Caplets
Sominex Nighttime Sleep Aid
Compoz Nighttime Sleep Aid
Nighttime Sleep Aid
Twilite Caplets
Benadryl Allergy Chewables
Children's

Pfizer

Benadryl Allergy Ultratab

Pfizer

Pfizer
Rugby
Alpharma, Teva
Rugby

Teva
Bayer
GlaxoSmithKline
GlaxoSmithKline
Medtech
Rugby
Pfeiffer
Pfizer

AllerMax Caplets
Pfeiffer
Simply Sleep Nighttime Sleep
McNeil
Aid Caplets
Sominex Caplets Maximum
GlaxoSmithKline
Strength
Parenteral Injection
50 mg/mL* Benadryl
Pfizer
Diphenhydramine
Hydrochloride Injection
* available from one or more manufacturer, distributor, and/or repackager by generic
(nonproprietary) name
50 mg

Diphenhydramine Citrate and Acetaminophen

Dosage
Routes
Strengths
Forms
38 mg/packet with 500
Oral For solution
mg/packet Acetaminophen
25 mg/15 mL with
Solution
Acetaminophen 500 mg/15mL
Tablets, film- 38 mg with Acetaminophen

Brand Names

Manufacturer

Goody's PM
GlaxoSmithKline
Powder
Tylenol PM Vanilla
McNeil
Liquid
Bayer PM Extra
Bayer

coated

500 mg

Strength Caplets
Excedrin P.M.
Caplets
Excedrin P.M.
Geltabs
Excedrin P.M.
Tablets

Other Diphenhydramine Citrate Combinations

Routes Dosage Forms Strengths
Tablets, for
Oral
38 mg with Aspirin 325 mg
solution
19 mg (equivalent to
Tablets, orally Diphenhydramine Hydrochloride
disintegrating 12.5 mg) with Pseudoephedrine
Hydrochloride 30 mg

Novartis
Novartis
Novartis

Brand Names
Alka-Seltzer
PM
Children's
Benadryl
Allergy & Cold
Fastmelt

Manufacturer
Bayer
Johnson &
Johnson

Diphenhydramine Hydrochloride Combinations

Dosage
Routes
Strengths
Brand Names
Manufacturer
Forms
12.5 mg/5 mL with
Acetaminophen 160 mg/5 mL,
Children's Tylenol
Oral Solution
McNeil
and Phenylephrine Hydrochloride Plus Cold and Allergy
2.5 mg/5 mL
12.5 mg/5 mL with Phenylephrine Children's Benadryl Johnson &
Hydrochloride 5 mg/5 mL
Allergy & Sinus Liquid Johnson
12.5 mg with Acetaminophen 325
Benadryl Allergy & Johnson &
Tablets
mg and Phenylephrine
Cold Caplets
Johnson
Hydrochloride 5 mg
Benadryl Allergy &
25 mg with Acetaminophen 325
Sinus Headache
Johnson &
mg and Phenylephrine

Caplets Maximum
Johnson
Hydrochloride 5 mg
Strength
25 mg with Acetaminophen 500 Tylenol PM Rapid
McNeil
mg
Release Gels
Tylenol PM Extra
McNeil
Strength Geltabs
25 mg with Magnesium Salicylate
580 mg (equivalent to 467.2 mg Doan's P.M. Extra
Novartis
of anhydrous magnesium
Strength Caplets
salicylate)
Tablets, 12.5 mg with Acetaminophen 325 Benadryl Allergy &
Johnson &
filmmg and Phenylephrine
Cold Caplets
Johnson
coated
Hydrochloride 5 mg
Maximum Strength
Sudafed MultiSymptom Severe Cold Pfizer
Caplets
12.5 mg with Acetaminophen 500 Percogesic Aspirin- Medtech

mg

25 mg with Acetaminophen 325

mg and Phenylephrine
Hydrochloride 5 mg

25 mg with Acetaminophen 500

mg
25 mg with Phenylephrine
Hydrochloride 10 mg
50 mg with Acetaminophen 500
mg

Free Caplets Extra

Strength
Tylenol Severe
McNeil
Allergy Caplets
Benadryl Severe
Johnson &
Allergy & Sinus
Johnson
Headache Caplets
Tylenol Allergy MultiSymptom Nighttime
McNeil

Cool Burst Caplets

Tylenol PM Caplets McNeil
Benadryl-D Allergy & Johnson &
Sinus
Johnson
Legatrin PM Caplets Columbia

Comparative Pricing
This pricing information is subject to change at the sole discretion of DS Pharmacy. This
pricing information was updated 03/2011. For the most current and up-to-date pricing
information, please visit www.drugstore.com. Actual costs to patients will vary depending on
the use of specific retail or mail-order locations and health insurance copays.
DiphenhydrAMINE HCl 25MG Capsules (QUALITEST): 100/$12.99 or 200/$14.98
DiphenhydrAMINE HCl 50MG Capsules (MAJOR PHARMACEUTICALS): 100/$13.99 or
200/$16.98
Duratuss AC 12 15-12.5-15MG/5ML Suspension (VICTORY PHARMA): 473/$215.99 or
1419/$609.96
Use is not currently included in the labeling approved by the US Food and Drug

Administration.
References
101. Parke-Davis. Benadryl (diphenhydramine hydrochloride injection) prescribing
information. New York, NY; 2001 May.
102. Tang AW. A practical guide to anaphylaxis. Am Fam Physician. 2003; 68:1325-32.
[PubMed 14567487]
103. Joint Task Force on Practice Parameters. The diagnosis and management of anaphylaxis. J
Allergy Clin Immunol. 1998; 101:S465-528.

104. Crismon ML and Canales PL. Insomnia. In: American Pharmaceutical Association.
Handbook of nonprescription drugs. 13th ed. Washington, DC: American Pharmaceutical
Association; 2002;971-84.
105. Oderda GM and Shane-McWhorter L. Nausea and vomiting. In: American Pharmaceutical
Association. Handbook of nonprescription drugs. 13th ed. Washington, DC: American
Pharmaceutical Association; 2002;390-410.
106. Lee NP and Arriola EP. How to treat allergic rhinitis. West J Med. 1999; 171: 31-4.
[PubMed 10483343] [Free Fulltext PMC]
107. Novartis Consumer Health, Inc. Excedrin PM (acetaminophen, diphenhydramine citrate)
caplets patient information. From Novartis Consumer Health website. Accessed 2008 Feb 21.
[Web]
108. McNeil-PPC, Inc. Benadryl Allergy & Cold (acetaminophen, diphenhydramine
hydrochloride, phenylephrine hydrochloride) caplets patient information. From McNeil-PPC
website. Accessed 2008 Feb 21. [Web]
109. McNeil-PPC, Inc. Tylenol PM (acetaminophen, diphenhydramine hydrochloride) rapid
release gels, caplets, geltabs, and oral solution patient information. From McNeil-PPC
website. Accessed 2008 Feb 21. [Web]
110. McNeil-PPC, Inc. Tylenol Allergy Multi-Symptom Nighttime (acetaminophen,
diphenhydramine hydrochloride, phenylephrine hydrochloride) caplets patient information.
From McNeil-PPC website. Accessed 2008 Feb 21. [Web]
111. GlaxoSmithKline Consumer Healthcare, LP. Goody's PM (acetaminophen,
diphenhydramine citrate) powder patient information. From GlaxoSmithKline Consumer
Healthcare website. Accessed 2008 Feb 22. [Web]
112. McNeil-PPC, Inc. Benadryl-D Allergy & Sinus (diphenhydramine hydrochloride,
phenylephrine hydrochloride) tablets patient information. From McNeil-PPC website.
Accessed 2008 Feb 25. [Web]
113. Bayer Healthcare LLC. Alka-Seltzer PM (aspirin, diphenhydramine citrate) effervescent
tablets patient information. From Bayer Healthcare website. Accessed 2008 Feb 25. [Web]
114. McNeil-PPC, Inc. Children's Benadryl Allergy & Cold Fastmelt (diphenhydramine citrate,
pseudoephedrine hydrochloride) tablets patient information. From McNeil-PPC website.
Accessed 2008 Feb 25. [Web]
a. AHFS drug information 2003. McEvoy GK, ed. Diphenhydramine. Bethesda, MD: American
Society of Health-System Pharmacists; 2003:24-8.
c. AHFS drug information 2003. McEvoy GK, ed. Antihistamines General Statement. Bethesda,
MD: American Society of Health-System Pharmacists; 2003:2-9.
HID. Trissel LA. Handbook on injectable drugs. 14th ed. Bethesda, MD: American Society of
Health-System Pharmacists; 2007:535-44.