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diphenhydramine by Sam's West Inc

Medically reviewed on June 11, 2018

Dosage form: tablet, coated
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Sam's West Inc
NDC Code: 68196-929

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.

Members Mark 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:
    • runny nose
    • itchy, watery eyes
    • sneezing
    • itching of the nose or throat
  • temporarily relieves these symptoms due to the common cold:
    • runny nose
    • sneezing 

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
  • 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
  • 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
  • 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
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • protect from moisture
  • use by expiration date on package 

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 8:30 AM to 4:00 PM ET, Monday - Friday 

Principal Display Panel

Compare to Benadryl® Allergy
Ultratab® active ingredient*

Member's Mark®
QUALITY GUARANTEED

NDC 68196-929-78

diphenhydramine
diphenhydramine HCl
25 mg
antihistamine

For allergy relief of
• sneezing
• runny nose
• itchy, watery eyes
• itchy throat or nose

actual
size

600
Tablets

Comments or Questions?
Call 1-800-426-9391
from 8:30 a.m. to 4:00 p.m. ET
Monday - Friday

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Benadryl® Allergy Ultratab®.
50844        ORG051232978

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

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

Members Mark 44-329

DIPHENHYDRAMINE 
diphenhydramine hcl tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68196-929
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
D&C RED NO. 27 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
SILICON DIOXIDE 
STEARIC ACID 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorPINKScoreno score
ShapeOVALSize11mm
FlavorImprint Code44;329
Contains    
Packaging
#Item CodePackage Description
1NDC:68196-929-78600 TABLET, COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34103/02/1990
Labeler - Sam's West Inc (051957769)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(68196-929)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(68196-929)

 
Sam's West Inc

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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