DIPHENHYDRAMINE HCL - diphenhydramine hydrochloride capsule 
Cardinal Health

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Active ingredient

(in each capsule)

Diphenhydramine Hydrochloride 50 mg

Purpose

Antihistamine

Keep Out of Reach of Children

Keep out of reach of children.

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies and common cold, sneezing, runny nose, itchy, watery eyes, itchy throat and nose.

When using this product you may get 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, do not use any other products containing diphenhydramine.

Warnings

Ask a doctor before use if you have glaucoma, a breathing problem such as emphysema or chronic bronchitis, trouble urinating due to an enlarged prostate gland.

This package is intended for institutional use only. Ask a doctor or pharmacist before use if you are taking tranquilizers or sedative. If pregnant or breast-feeding, ask a health professional before use. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DIRECTIONS

adults and children 12 years and over

take 50 mg (1 capsule) every 4 to 6 hours; not more than 6 capsules in 24 hours.
children under 12 yearsask a doctor, the proper dosage strength is not available in this package**

**Do not attempt to break capsules. The proper dosage strength and dosing information for children under 12 years of age is available on the 25 mg. package.

STORAGE: Store at Controlled Room Temperature (59-86)

Protect from excessive moisture.

Inactive ingredients

D&C Red #28, FD&C Blue #1, FD&C Red #40, Gelatin, Lactose and Starch

Distributed by

Major Pharmaceuticals

31778 Enterprise Drive

Livonia, MI 48150 USA

MFGD By Contract Pharm., NY 11788

Questions? Adverse Drug Event

Call: (800) 616-2471

Repackaged by Cardinal Health

Zanesville, OH 43701

Package/Label Principal Display Panel

Diphenhydramine HCl

Capsules 50 mg.

10 Capsules

bag label

DIPHENHYDRAMINE HCL 
diphenhydramine hcl capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-0661(NDC:0904-2056)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE50 mg
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 28 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GELATIN 
LACTOSE 
STARCH, CORN 
Product Characteristics
ColorPINK (red center band) Score no score
ShapeCAPSULESize15mm
FlavorImprint Code CPC;836
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:55154-0661-010 BLISTER PACK ( BLISTER PACK) in 1 BAGcontains a BLISTER PACK
11 CAPSULE ( CAPSULE) in 1 BLISTER PACKThis package is contained within the BAG (55154-0661-0)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other07/26/2011

Labeler - Cardinal Health (188557102)
Establishment
NameAddressID/FEIOperations
Cardinal Health188557102REPACK

Revised: 07/2011 Cardinal Health