ALLERGY- diphenhydramine hcl tablet, film coated 
GREENBRIER INTERNATIONAL, INC.

----------

Assured 44-329-Delisted

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 over1 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

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

*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

Assured 44-329

Assured 44-329

ALLERGY 
diphenhydramine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-0329
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorpinkScoreno score
ShapeOVALSize11mm
FlavorImprint Code 44;329
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:33992-0329-71 in 1 CARTON03/02/199002/26/2021
136 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:33992-0329-11 in 1 CARTON03/02/199002/26/2021
245 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01203/02/199002/26/2021
Labeler - GREENBRIER INTERNATIONAL, INC. (610322518)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464pack(33992-0329)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837manufacture(33992-0329) , pack(33992-0329)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894manufacture(33992-0329)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088manufacture(33992-0329)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305pack(33992-0329)

Revised: 10/2023
Document Id: 82b4be0a-9425-4eb9-99ab-4ea463dcd500
Set id: 74681d44-6de1-41e5-9f42-4639fa604256
Version: 11
Effective Time: 20231021
 
GREENBRIER INTERNATIONAL, INC.