Label: DIPHENHYDRAMINE HYDROCHLORIDE capsule

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated November 22, 2016

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  • ACTIVE INGREDIENT (IN EACH CAPSULE)
    Diphenhydramine HCl 25 mg
  • PURPOSE
    Antihistamine
  • USES
    temporarily relieves these symptoms of hay fever or other upper respiratory allergies: runny nose - sneezing - itchy nose or throat - itchy, watery eyes
  • WARNINGS
    ​Do not use​ with any other product containing diphenhydramine, even one used on skin - ​Ask a doctor before use if you have - ​glaucoma - trouble urinating due to an enlarged prostate gland - a ...
  • KEEP OUT OF THE REACH OF CHILDREN.
    In case of overdose, get medical help or contact a Poison Control Venter right away.
  • DIRECTIONS
    adults & children 12 years and over: take 1-2 capsules every 4-6 hours; not more than 6 does in 24 hours - ​children under 12 years: ask a doctor
  • OTHER INFORMATION
    store at 15°-30°C (59°-86°F) protect from moisture - This is a bulk package. Dispense contents in a tight, light-resistant container with a child-resistant closure as defined in the USP
  • INACTIVE INGREDIENTS
    benzyl alcohol, butylparaben, D&C red #28, edible black ink, FD&C blue #1, FD&C red #40, gelatin, lactose, magnesium stearate, methylparaben, polysorbate 80, propylparaben, sodium lauryl ...
  • QUESTIONS OR COMMENTS?
    call ​888-374-279​ 1, 8:30 am - 4:30 pm ET, Monday - Friday - ​TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFTEY SEAL UNDER CAP OR BAND AROUND ANY CAPSULE IS MISSING OR ...
  • PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 25 MG
    ​Diphenhydramine HCl Capsules, USP​ ​25 mg - ​ANTIHISTAMINE - ​1000 Capsules - ​THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN
  • INGREDIENTS AND APPEARANCE
    Product Information