DIPHENHYDRAMINE- diphenhydramine hcl capsule, 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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Simply Right 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:

    • 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

  • do not take more than 6 doses in 24 hours

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 this product in children under 6 years of age

Other information

  • store at controlled room temperature 15°-30°C (59°-86°F)

  • 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

Principal Display Panel

SIMPLY RIGHT™
Health Care

NDC 68196-329-78

diphenhydramine
diphenhydramine HCl 25 mg | antihistamine

Compare To The Active Ingredient of Benadryl® Allergy Ultratab®*

for allergy relief
sneezing
runny nose
itchy, watery eyes
itchy throat or nose

600 tablets

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

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

Simply Right 44-329

Simpy Right 44-329

DIPHENHYDRAMINE 
diphenhydramine hcl capsule, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68196-329
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
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorPINKScoreno score
ShapeCAPSULESize11mm
FlavorImprint Code 44;329
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68196-329-78600 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34103/02/199004/02/2018
Labeler - Sam's West Inc (051957769)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(68196-329)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(68196-329)

Revised: 10/2015
Document Id: 3490a89b-dbf5-4a35-bbd6-a117239c42a0
Set id: 0cf64eac-7c5a-444c-9e1d-e39246b08dc9
Version: 2
Effective Time: 20151009
 
Sam's West Inc