SLEEP AID- diphenhydramine hcl tablet 
Best Choice (Valu Merchandisers Company)

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

Nighttime sleep-aid

Use

Helps to reduce difficulty falling asleep.

Warnings

Do not use

  • for children under 12 years of age
  • 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,

avoid alcoholic drinks.

Stop use and ask a doctor if

sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.

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 of age and over: take 2 tablets at bedtime if needed or as directed by a doctor

Other information

  • each tablet contains: calcium 65 mg
  • store at 15º-30ºC (59º-86ºF)

Inactive ingredients

croscarmellose sodium, dicalcium phosphate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

COMPARE TO THE ACTIVE INGREDIENT IN SOMINEX®*

ORIGINAL STRENGTH

NIGHTTIME

Sleep Aid

DIPHENHYDRAMINE HCl 25 mg

Wake Rested and Refreshed

Nighttime Sleep-Aid

TABLETS

25 mg Each

*This product is not manufactured or distributed by Prestige Brands, Inc., owner of the registered trademark Sominex®.

PROUDLY DISTRIBUTED BY:

VALU MERCHANDISERS, CO.

5000 KANSAS AVE

KANSAS CITY, KS 66106

www.bestchoicebrand.com

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Package Label

Diphenhydramine HCl 25 mg

Best Choice Nighttime Sleep Aid Tablet

SLEEP AID 
diphenhydramine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63941-052
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
Product Characteristics
ColorBLUEScore2 pieces
ShapeROUNDSize10mm
FlavorImprint Code 1008;1008
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63941-052-1616 in 1 CARTON04/30/201412/30/2020
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33804/30/201412/30/2020
Labeler - Best Choice (Valu Merchandisers Company) (868703513)

Revised: 7/2019
Document Id: 0bc68fb7-fb81-4a08-9d47-8019bdf16d8d
Set id: 73b43d1d-0496-4f82-b96b-39d08e217052
Version: 2
Effective Time: 20190710
 
Best Choice (Valu Merchandisers Company)