COMPLETE ALLERGY- diphenhydramine hydrochloride tablet 
GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.

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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Healthcare 44-329

Active ingredient (in each tablet)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses

Warnings

Do not use

  • to make a child sleepy

  • with 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

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

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

Questions or comments?

Call 1-800-4266-9391

Principal Display Panel

HEALTHCARE™
NDC 64092-830-24

Complete
Allergy
Antihistamine
Diphenhydramine HCl 25 mg

Relieves:
Runny Nose              •Sneezing
Itchy Troat                 •Itchy, Watery Eyes

Easy-to-Swallow

*Compare to the active ingredient in Benadryl® Allergy Ultratab®

24 MINITABS

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Benadryl® Allergy Ultratab®. 
50844             REV0410E32908

Distributed by:
Great Lakes Wholesale & Marketing L.L.C.
3729 Patterson Ave., S.E.
Grand Rapids, MI 49512

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS SIGNS OF TAMPERING

Healthcare 44-329

Healthcare 44-329

COMPLETE ALLERGY 
diphenhydramine hcl tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:64092-830
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Color PINK Score no score
Shape CLOVER Size 11mm
Flavor Imprint Code 44;329
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:64092-830-24 1 in 1 CARTON
1 24 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part341 03/02/1990
Labeler - GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. (361925498)
Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 832867894 MANUFACTURE(64092-830)
Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 038154464 PACK(64092-830)

Revised: 11/2012
Document Id: 7146b021-2a60-4787-ac39-d28c6396ca11
Set id: 1c041e23-3d49-4be1-82d2-50cca641fa0f
Version: 4
Effective Time: 20121115
 
GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.