Your browser does not support JavaScript! SLEEP ORIGINAL FORMULA (DIPHENHYDRAMINE HCL) TABLET [BEST CHOICE (VALU MERCHANDISERS COMPANY)]
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RxNorm Names

SLEEP ORIGINAL FORMULA (diphenhydramine hcl) tablet
[Best Choice (Valu Merchandisers Company)]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

Active ingredient (in each tablet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Use

helps reduce difficulty falling asleep

Warnings

Do not give to children under 12 years of age.

Do not use this product

with other products containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

  • emphysema

  • chronic bronchitis

  • glaucoma

  • difficulty in urination due to an enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

When using this product

avoid alcoholic beverages.

stop use and ask a doctor if

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

If pregnant or breast-feeding,

ask a health care 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 over: take 2 tablets at bedtime if needed or as directed by a doctor. For best results, take recommended dose.

Other information

  • each tablet contains: calcium 65 mg
  • store at controlled room temperature 15°-30°C (59°-86°F)
  • avoid excessive heat and humidity

Inactive ingredients

croscarmellose sodium, dicalcium phosphate, FD&C Blue #1 aluminium lake, magnesium stearate and microcrystalline cellulose

May also contain: silicon dioxide and stearic acid

Principal Display Panel

Compare to the active ingredient in Sominex®*

*This product is not manufactured or distributed by Glaxosmithkline, owner of the registered trademark Sominex®

SLEEP TABLETS

wake rested and refreshed

Nighttime Sleep-Aid

Diphenhydramine HCl 25 mg

PROUDLY DISTRIBUTED BY:

VALU MERCHANDISERS, CO.

KANSAS CITY, MO 64111

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

THIS PRODUCT IS PACKAGED IN A CHILD RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.

Product Label

best choice valu merchandisers

Nighttime sleep-aid

SLEEP  ORIGINAL FORMULA
diphenhydramine hcl tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:63941-200
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
SILICON DIOXIDE 
FD&C BLUE NO. 1 
STEARIC ACID 
ALUMINUM OXIDE 
Product Characteristics
ColorBLUEScore2 pieces
ShapeROUNDSize10mm
FlavorImprint Code 1008;1008
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63941-200-162 in 1 CARTON
18 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33607/16/2010
Labeler - Best Choice (Valu Merchandisers Company) (868703513)
Registrant - P and L Development of New York Corporation (800014821)

Revised: 11/2012
 
Best Choice (Valu Merchandisers Company)

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