Diphenhydramine Hydrochloride 25 mg

DIPHENHYDRAMINE HCL - diphenhydramine hydrochloride tablet 
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

Drug Facts

(in each tablet)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Keep Out of Reach of Children

In case of overdose, get medical help or contact a Poison Control Center right away.This package is intended for institutional use only. Keep this and all drugs out of the reach of children. This unit dose package is not child resistant.

Uses

■temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

■runny nose ■itchy, watery eyes

■sneezing ■itching of the nose or throat

■temporarily relieves these symptoms due to the common cold:

■runny nose ■sneezing

Warnings

TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.

Do not use ■to make a child sleepy

■with any other product containing diphendydramine, even one used on skin

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

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

When using this product

■marked drowsiness may occur.

■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

Directions

■take every 4 to 6 hours

■do not take more than 6 doses in 24 hours

adults and children

12 years of age and over 1 to 2 tablets

children 6 to under

12 years of age 1 tablet

children under 6 years of age do not use this product in chil-

dren under 6 years of age

Inactive ingredients

Corn Starch, D&C red #27 aluminum lake, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide

Storage

■Store at 20° to 25° C (68° to 77° F). [See USP Controlled Room Temperature.]

■Protect from moisture.

■use by expiration date on blister package

Questions?

1-800-848-0462

■Serious side effects associated with use of this products may be reported to this number.

How Supplied:

Diphenhydramine Hydrochloride Tablets are available as follows:
25 mg - Pink film coated capsule shaped tablet imprinted with 44-329 on one side.

NDC 51079-967-20 - Unit dose blister packages of 100 (10 cards or 10 tablets each).

NDC51079-967-19 - Robot Ready blister packages of 25 (25 cards of 1 tablet each).

Manufactured by:

LNK International, Inc.

Hauppauge, NY 11788

Distributed by:

UDL Laboratories, Inc.

Rockford, IL 61103

S-8805 R4

7/10

Principal Display Panel

Diphenhydramine Hydrochloride Tablets

25 mg

10 Tablets

bag label

DIPHENHYDRAMINE HCL 
diphenhydramine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-5482(NDC:51079-967)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
D&C RED NO. 27 
ANHYDROUS DIBASIC CALCIUM PHOSPHATE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POLYVINYL ALCOHOL 
SILICON DIOXIDE 
STEARIC ACID 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorPINKScore no score
ShapeCAPSULESize11mm
FlavorImprint Code 44;329
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:55154-5482-010 BLISTER PACK ( BLISTER PACK) in 1 BAGcontains a BLISTER PACK
11 TABLET ( TABLET) in 1 BLISTER PACKThis package is contained within the BAG (55154-5482-0)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other06/03/2011

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

Revised: 06/2011 Cardinal Health