ALLERGY- diphenhydramine hydrochloride tablet 
GREENBRIER INTERNATIONAL, 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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Assured 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

  • a breathing problem such as emphysema or chronic bronchitis

  • glaucoma

  • 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

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 and over

1 to 2 tablets 
 children 6 to under 12 years  1 tablet   
 children under 6 years  do not use

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?

1-800-426-9391 

Principal Display Panel

ASSUREDâ„¢

COMPARE TO ACTIVE INGREDIENT OF BENADRYL® ALLERGY ULTRATAB®*

Allergy

• Diphenhydramine HCl 25 mg
  Antihistamine

  Sneezing, Runny Nose, Itchy Throat,
  Itchy, Watery Eyes

Actual Size

36 Tablets

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Benadryl® Allergy Ultratab®.
50844    REV0512C32907

Distributed by:
Greenbrier International, Inc.
Chesapeake, VA 23320

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

Assured 44-329

Assured 44-329

ALLERGY 
diphenhydramine hcl tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:33992-0329
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 CAPSULE Size 11mm
Flavor Imprint Code 44;329
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:33992-0329-7 1 in 1 CARTON
1 36 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part341 03/02/1990
Labeler - GREENBRIER INTERNATIONAL, INC. (610322518)
Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 038154464 PACK(33992-0329)
Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 832867894 MANUFACTURE(33992-0329)

Revised: 9/2014
Document Id: 8ea47395-8d99-41d0-9caa-03698d3a61c6
Set id: 74681d44-6de1-41e5-9f42-4639fa604256
Version: 2
Effective Time: 20140902
 
GREENBRIER INTERNATIONAL, INC.