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Name:Allergy Medicine
Manufacturer:Costco Wholesale Corporation
Category:Over-the-counter (OTC) Marketed Drugs


Kirkland 44-329

ALLERGY MEDICINE - diphenhydramine hydrochloride tablet 
COSTCO WHOLESALE CORPORATION

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.

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Kirkland 44-329

Active ingredient(s)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Use(s)

  • 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

Do not use

  • to make a child sleepy

  • ith any other product containing diphenhydramine, 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

  • may occur, especially in children

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.

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 children under 6 years of age

Other information

  • store at controlled room temperature 15°-30°C (59°-86°F)

  • protect from moisture

  • see end flap for expiration date and lot number

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

Principal Display Panel

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

KIRKLAND™

Signature

NDC 63981-329-78

ITEM # 536099

COMPARE TO BENADRYL®

ALLERGY ULTRATAB™

active ingredient*

ALLERGY

MEDICINE

Diphenhydramine HCl 25 mg

Antihistamine • Allergy Relief

For Temporary Relief Of:

Sneezing & Runny Nose

Ithcy, Watery Eyes

Hay Fever Symptoms

Itching of Nose or Throat

Actual Size

600 MINITABS

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

50844      ORG041032978

Manufactured byL LNK INTERNATIONAL, INC.

60 Arkay Drive, Hauppauge, NY 11788 USA

For Costco Wholesale Corporation, P.O. Box 34535

Seattle, WA 98124-1535 USA     1-800-426-9391          www.costco.com

Product Packaging

Product Packaging


ALLERGY MEDICINE 
diphenhydramine hcl tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63981-329
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE  
D&C RED NO. 27  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE  
MAGNESIUM STEARATE  
POLYETHYLENE GLYCOL  
POLYVINYL ALCOHOL  
SILICON DIOXIDE  
STEARIC ACID  
TITANIUM DIOXIDE  
Product Characteristics
Color PINK Score no score
Shape CLOVER Size 11mm
Flavor Imprint Code 44;329
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63981-329-78 1 BOTTLE, PLASTIC (1 BOTTLE) in 1 CARTON contains a BOTTLE, PLASTIC
1 600 TABLET (600 TABLET) in 1 BOTTLE, PLASTIC This package is contained within the CARTON (63981-329-78)
2 NDC:63981-329-05 1 BOTTLE, PLASTIC (1 BOTTLE) in 1 CARTON contains a BOTTLE, PLASTIC
2 400 TABLET (400 TABLET) in 1 BOTTLE, PLASTIC This package is contained within the CARTON (63981-329-05)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part341 03/02/1990

Labeler - COSTCO WHOLESALE CORPORATION (103391843)

Revised: 02/2011 COSTCO WHOLESALE CORPORATION



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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