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Diphenhydramine Hydrochloride by Epic Pharma, LLC

Medically reviewed on November 22, 2016

Dosage form: capsule
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Epic Pharma, LLC
NDC Code: 42806-648

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.

DIPHENHYDRAMINE HYDROCHLORIDE CAPSULES, USP 25 mg

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 breathing problem such as emphysema or chronic bronchitis

​Ask a doctor or pharmacist before use if you are​ taking sedatives or tranqulizers

​When using this product

  • ​you may get very drowsy
  • avoid alcoholic drinks
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

​If pregnant or breast-feeding​, ask a health professional before use.

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 sulfate

QUESTIONS OR COMMENTS?

call ​888-374-2791, 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 DAMAGED

​Distributed by:

Epic Pharma, LLC

Laurelton, NY

11413

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 25 MG

​Diphenhydramine HCl Capsules, USP​25 mg

​ANTIHISTAMINE

​1000 Capsules

​THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42806-648
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL 
BUTYLPARABEN 
D&C RED NO. 28 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GELATIN 
LACTOSE 
MAGNESIUM STEARATE 
METHYLPARABEN 
POLYSORBATE 80 
PROPYLPARABEN 
SODIUM LAURYL SULFATE 
Product Characteristics
ColorpinkScoreno score
ShapecapsuleSize14mm
FlavorImprint CodeAP;020
Contains    
Packaging
#Item CodePackage Description
1NDC:42806-648-101000 CAPSULE in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34111/22/2016
Labeler - Epic Pharma, LLC (827915443)

 
Epic Pharma, LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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