ALLER-BEN- diphenhydramine hcl tablet, film coated 
Sam's West 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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Members Mark 44-329 Aller-Ben

Active ingredient (in each tablet)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses

Warnings

Do not use

  • 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
  • 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 right away.

Directions

adults and children 12 years and over1 to 2 tablets
children 6 to under 12 years1 tablet
children under 6 yearsdo not use

Other information

Inactive ingredients

corn starch, D&C red #27 aluminum lake, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide

Questions or comments?

1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

Principal display panel

Compare to Benadryl® Allergy Ultratab® active ingredient*

NDC 68196-829-78

Member's Mark™

Aller-Ben™

Diphenhydramine HCl 25 mg
Antihistamine
Allergy

For Allergy Relief of
•Sneezing  •Runny Nose
•Itchy, Watery Eyes
•Itchy Throat or Nose

actual size

600 Tablets

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

Comments or Questions?
Call 1-800-426-9390
from 8:30a.m. to 4:00p.m. ET
Monday-Friday

*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Benadryl® Allergy Ultratab®.
50844     REV1220A32978

DISTRIBUTED BY: SAM'S WEST, INC., BENTONVILLE, AR 72716

Members Mark 44-329

Members Mark 44-329

ALLER-BEN 
diphenhydramine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68196-829
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)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
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:68196-829-78600 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/18/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/18/2020
Labeler - Sam's West Inc (051957769)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894manufacture(68196-829)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088manufacture(68196-829) , pack(68196-829)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837pack(68196-829)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305pack(68196-829)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464pack(68196-829)

Revised: 7/2021
Document Id: 8622ee89-161b-4db0-be59-a8b6f7596d8e
Set id: 55d4f1c3-a97b-4b33-a392-7cab00b56de5
Version: 3
Effective Time: 20210706
 
Sam's West Inc