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Name:Nighttime Sleep Aid
Manufacturer:Woonsocket Prescription Center,incorporated
Category:Over-the-counter (OTC) Marketed Drugs


CVS 44-367

NIGHTTIME SLEEP AID - diphenhydramine hydrochloride tablet, film coated 
WOONSOCKET PRESCRIPTION CENTER,INCORPORATED

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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CVS 44-367

Active ingredient(s)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Uses

  • relief of occasional sleeplessness

Warnings

Do not use

  • in children under 12 years of age

  • with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if

  • 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

  • taking sedatives or tranquilizers

When using this product

  • drowsiness will occur

  • avoid alcoholic drinks

  • do not drive a motor vehicle or operate machinery

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

Overdose warning: In case of overdose, get medical help or In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical even if you do not notice any signs or symptoms.

Directions

  • do not take more than directed (see Overdose warning)

  • adults and children 12 years and over: take 2 caplets at bedtime if needed or as directed by a doctor

  • children under 12 years: do not use

Other information

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

  • see end flap for expiration date and lot number

Inactive ingredients

corn starch, dicalcium phosphate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silica gel, stearic acid, talc, titanium dioxide

Questions or comments?

1-800-426-9391

Principal Display Panel

CVS®

pharmacy

NDC 59779-367-22

Compare to the active ingredient in Simply Sleep®*

NIGHTTIME

SLEEP AID

MINI-CAPLETS

DIPHENHYDRAMINE HCL

• For a restful night's sleep

•Safe, non-habit forming

Does not contain

Pain Reliever

This package for households

without young children

48

Mini-Caplets

Product Label

CVS 44-367


NIGHTTIME SLEEP AID 
diphenhydramine hcl tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-367
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE  
FD&C BLUE NO. 1  
MAGNESIUM STEARATE  
CELLULOSE, MICROCRYSTALLINE  
POLYETHYLENE GLYCOL  
POLYVINYL ALCOHOL  
STEARIC ACID  
TALC  
TITANIUM DIOXIDE  
Product Characteristics
Color BLUE Score no score
Shape CAPSULE Size 13mm
Flavor Imprint Code 44;367
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59779-367-22 1 BLISTER PACK (1 BLISTER PACK) in 1 CARTON contains a BLISTER PACK
1 48 TABLET, FILM COATED (48 TABLET) in 1 BLISTER PACK This package is contained within the CARTON (59779-367-22)
2 NDC:59779-367-23 1 BLISTER PACK (1 BLISTER PACK) in 1 CARTON contains a BLISTER PACK
2 72 TABLET, FILM COATED (72 TABLET) in 1 BLISTER PACK This package is contained within the CARTON (59779-367-23)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part338 06/10/2000

Labeler - WOONSOCKET PRESCRIPTION CENTER,INCORPORATED (062312574)

Revised: 05/2011 WOONSOCKET PRESCRIPTION CENTER,INCORPORATED



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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