Diphenhydramine (oral)

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Diphenhydramine (oral)
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Adeel Jamil, M.D. [2]

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NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Overview

Diphenhydramine (oral) is an analgesic and antihistamine that is FDA approved for the treatment of temporarily relieves symptoms of the common cold such as runny nose, sneezing, itchy watery eyes, and itchy nose or throat. Common adverse reactions include xerostomia, dizziness, dyskinesia, sedation, somnolence, dryness of nasal mucosa, pharyngeal dryness, and thick sputum.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

  • Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  • Temporarily relieves these symptoms of the common cold:
  • Dosing Information
  • Take every 4 to 6 hours, not more than 6 doses in 24 hours
This image is provided by the National Library of Medicine.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Diphenhydramine in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non-Guideline-Supported Use of Diphenhydramine in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Diphenhydramine (oral) in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Diphenhydramine in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Diphenhydramine in pediatric patients.

Contraindications

Warnings

When using this product marked drowsiness may occur avoid alcoholic drinks excitability may occur, especially in children alcohol, sedatives and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Adverse Reactions

Clinical Trials Experience

Digestive

Neurologic
Respiratory
Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Diphenhydramine in the drug label.

Drug Interactions

There is limited information regarding drug interactions of Diphenhydramine in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): B

  • Pregnancy Category


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Diphenhydramine in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Diphenhydramine during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Diphenhydramine with respect to nursing mothers.

Pediatric Use

  • Keep out of reach of children.
  • In case of overdose, get medical help or contact a Poison Control Center right away.

Geriatic Use

There is no FDA guidance on the use of Diphenhydramine with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Diphenhydramine with respect to specific gender populations.

Race

There is no FDA guidance on the use of Diphenhydramine with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Diphenhydramine in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Diphenhydramine in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Diphenhydramine in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Diphenhydramine in patients who are immunocompromised.

Administration and Monitoring

Administration

Monitoring

There is limited information regarding Monitoring of Diphenhydramine in the drug label.

IV Compatibility

There is limited information regarding IV Compatibility of Diphenhydramine in the drug label.

Overdosage

There is limited information regarding Chronic Overdose of Diphenhydramine in the drug label.

Pharmacology

Template:Px
Template:Px
Diphenhydramine (oral)
Systematic (IUPAC) name
2-(diphenylmethoxy)-N,N-dimethylethanamine
Identifiers
CAS number 58-73-1
ATC code D04AA32 D04AA33 (WHO), R06AA02 (WHO)
PubChem 3100
DrugBank DB01075
Chemical data
Formula Template:OrganicBox atomTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox 
Mol. mass 255.355 g/mol
SMILES eMolecules & PubChem
Pharmacokinetic data
Bioavailability 40–60%[1]
Protein binding 98–99%
Metabolism Various cytochrome P450 liver enzymes: CYP2D6 (80%), 3A4 (10%)[2]
Half life 8 hours (children)[3]
9 to 12 hours (adults)[3]
17 hours (elderly)[3]
Excretion 94% through the urine, 6% through feces[4]
Therapeutic considerations
Pregnancy cat.

A(AU) B(US)

Legal status

Pharmacy Only (S2)(AU) Over-the-counter

Dependence Liability Very low
Routes Oral, parenteral (IM and IV), topical, suppository

Mechanism of Action

Structure

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Diphenhydramine (oral) in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Diphenhydramine (oral) in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Diphenhydramine in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Diphenhydramine in the drug label.

How Supplied

  • Each tablet contains: calcium 20 mg

Storage

  • Store at 20°-25°C

Images

Drug Images

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This pill image is provided by the National Library of Medicine's PillBox.

Package and Label Display Panel

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This image of the FDA label is provided by the National Library of Medicine.

Patient Counseling Information

Precautions with Alcohol

Brand Names

  • Benadryl®
  • Benylin Decongestant Cough®
  • Diphenhist
  • Diphenyl®
  • Genahist®
  • Geridryl®
  • Nytol Quickcaps®
  • Nytol Quickgels®

Look-Alike Drug Names

  • Benadryl® - benazepril®
  • diphenhydrAMINE® - dimenhyDRINATE®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

  1. Paton DM, Webster DR (1985). "Clinical pharmacokinetics of H1-receptor antagonists (the antihistamines)". Clin. Pharmacokinet. 10 (6): 477–97. doi:10.2165/00003088-198510060-00002. PMID 2866055.
  2. "Showing Diphenhydramine (DB01075)". DrugBank. Retrieved 5 September 2009.
  3. 3.0 3.1 3.2 Simons KJ, Watson WT, Martin TJ, Chen XY, Simons FE (July 1990). "Diphenhydramine: pharmacokinetics and pharmacodynamics in elderly adults, young adults, and children". J. Clin. Pharmacol. 30 (7): 665–71. doi:10.1002/j.1552-4604.1990.tb01871.x. PMID 2391399.
  4. Garnett WR (February 1986). "Diphenhydramine". Am. Pharm. NS26 (2): 35–40. PMID 3962845.