ALLERGY RELIEF ANTIHISTAMINE- diphenhydramine hydrochloride tablet 
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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DRUG FACTS

Active ingredient (in each tablet)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses

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

  • a breathing problem such as emphysema or chronic bronchitis

  • glaucoma

  • 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 of 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. (1-800-222-1222)

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 take 1 to 2 tablets 
 children 6 to under 12 years of age take 1 tablet
 children under 6 years of age do not use this product in children under 6

Other information

  • each tablet contains: calcium 25 mg/tablet
  • store at room temperature 15°-30°C (59°-86°F)
  • protect from light and moisture

Inactive ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C Red #27 Aluminum Lake, dibasic calcium phosphate dihydrate, hypromellose, lecithin*, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polysorbate 80, polyvinyl alcohol*, purified water*, talc*, and titanium dioxide

* contains one or more of these ingredients

Questions or comments?

Call toll free 1-888-301-0332 Monday-Friday 8AM-5PM CST

Principal Display Panel

allergy relief

diphenhydramine

hydrochloride 25 mg | antihistamine

Compare to Benadryl® Allergy Ultratab® active ingredient**

for allergy relief

sneezing       itchy, watery eyes

runny nose    itchy throat or nose

tablets

**This product is not manufactured or distributed by McNeil Consumer Healthcare, Division of McNeil-PPC, Inc., owner of the registered trademark Benadryl® Allergy ULTRATAB®.

Distributed by:

SAM'S WEST, INC.,

BENTONVILLE, AR  72716

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

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

Product Label

Diphenhydramine HCl 25 mg

Simply Right Diphenhydramine HCl 25 mg Allergy Relief

ALLERGY RELIEF  ANTIHISTAMINE
diphenhydramine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68196-690
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
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorPINKScoreno score
ShapeCAPSULESize12mm
FlavorImprint Code T61;V25;S4
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68196-690-041 in 1 BOX10/30/201112/31/2019
1400 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33610/30/201112/31/2019
Labeler - Sam's West, Inc (051957769)
Registrant - P & L Development, LLC (800014821)

Revised: 12/2018
Document Id: f37e97f7-bf81-46ab-8e79-8549158fa2c3
Set id: ddbae550-26cb-4d8d-9b76-998754fa3aae
Version: 2
Effective Time: 20181221
 
Sam's West, Inc