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Allergy by GREENBRIER INTERNATIONAL, INC.

Medically reviewed on January 13, 2017

Dosage form: tablet, film coated
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: GREENBRIER INTERNATIONAL, INC.
NDC Code: 33992-0329

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.

Assured 44-329

Active ingredient (in each tablet)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses
  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • itchy, watery eyes
    • sneezing
    • runny nose
    • itching of the nose or throat
  • temporarily relieves these symptoms due to the common cold:
    • sneezing
    • runny nose

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
  • difficulty in urination due to enlargement of the 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 beverages
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • use caution 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 (1-800-222-1222) right away.

Directions
  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 times in 24 hours
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
  • each tablet contains: calcium 30 mg
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • 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

Questions or comments?

1-800-426-9391 

Principal Display Panel

ASSURED™

COMPARE TO ACTIVE INGREDIENT OF
BENADRYL® ALLERGY ULTRATAB® TABLETS*

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 Johnson & Johnson Corporation, owner of the registered trademark Benadryl® Allergy ULTRATAB Tablets®.
50844      REV1016D32907

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

ALLERGY 
diphenhydramine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem 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 
MAGNESIUM STEARATE 
POLYETHYLENE GLYCOLS 
SILICON DIOXIDE 
STEARIC ACID 
TITANIUM DIOXIDE 
TALC 
POLYVINYL ALCOHOL, UNSPECIFIED 
STARCH, CORN 
Product Characteristics
ColorPINKScoreno score
ShapeOVALSize11mm
FlavorImprint Code44;329
Contains    
Packaging
#Item CodePackage Description
1NDC:33992-0329-71 BOTTLE, PLASTIC in 1 CARTON
136 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
2NDC:33992-0329-11 BOTTLE, PLASTIC in 1 CARTON
246 TABLET, FILM COATED 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/FEIOperations
LNK International, Inc.038154464PACK(33992-0329)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(33992-0329)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088MANUFACTURE(33992-0329), PACK(33992-0329)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(33992-0329)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(33992-0329)

 
GREENBRIER INTERNATIONAL, INC.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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