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

  • 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

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

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

Principal Display Panel

ASSURED™

COMPARE TO ACTIVE INGREDIENT IN BENADRYL® ULTRATAB®*

Allergy
For the temporary relief of:
Itchy Throat
Runny Nose
Itchy, Watery Eyes
Sneezing

36 Tablets

Antihistamine • Diphenhydramine HCl 25 mg

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Benadryl® Allergy Ultratab®.
50844    REV0512B32907

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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:33992-0329
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE 
D&C RED NO. 27 
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS 
MAGNESIUM STEARATE 
POLYETHYLENE GLYCOLS 
POLYVINYL ALCOHOL 
SILICON DIOXIDE 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
ColorPINKScoreno score
ShapeCAPSULESize11mm
FlavorImprint Code 44;329
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:33992-0329-71 in 1 CARTON
136 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34103/02/1990
Labeler - GREENBRIER INTERNATIONAL, INC. (610322518)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(33992-0329)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(33992-0329)

Revised: 9/2013
Document Id: 2fb881f7-1d04-441c-8396-f27c076b6e08
Set id: 74681d44-6de1-41e5-9f42-4639fa604256
Version: 1
Effective Time: 20130917
 
GREENBRIER INTERNATIONAL, INC.