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NIGHTTIME SLEEP AID

Dosage form: capsule, liquid filled
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 50mg
Labeler: PuraVation Pharmaceuticals Inc
NDC code: 76270-109

NIGHTTIME SLEEP AID capsule, liquid filled

Drug Facts

Active ingredient (in each softgel)

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid

Uses
  • for relief of occasional sleeplessness

Warnings

  • do not give to children under 12 years of age
  • do not use 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 persist continuously for more than 2 weeks. Insomnia may be a symptom of 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: 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor.

Other information
  • store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat
  • do not use if imprinted safety seal under cap is broken or missing

Inactive ingredients

FD&C blue #1, gelatin, glycerin, polyethylene glycol, purified water, sorbitol special and white edible ink

PRINCIPAL DISPLAY PANEL

NIGHTTIME SLEEP AID

Liquidcaps

Maximum Strength

Diphenhydramine HCl 50 mg

32 Liquidcaps

Compare to the active ingredient in Maximum Strength Unisom Sleep Gels® 

NIGHTTIME SLEEP AID 
diphenhydramine hydrochloride 50 mg capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76270-109
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE50 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 
GELATIN 
GLYCERIN 
POLYETHYLENE GLYCOLS 
WATER 
SORBITOL 
Product Characteristics
ColorblueScoreno score
ShapeCAPSULE (OVAL) Size13mm
FlavorImprint CodePC5
Contains    
Packaging
#Item CodePackage Description
1NDC:76270-109-161 BOTTLE, PLASTIC (BOTTLE) in 1 CARTON
132 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BOTTLE, PLASTIC
2NDC:76270-109-171 BOTTLE, PLASTIC (BOTTLE) in 1 CARTON
264 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34104/15/2013
Labeler - PuraVation Pharmaceuticals Inc (968385034)
Establishment
NameAddressID/FEIOperations
Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.421293287MANUFACTURE(76270-109), ANALYSIS(76270-109)

Revised: 04/2013
Document Id: e93aca52-10ac-4cc6-9952-33491d8b4d03
Set id: 4400053d-e06f-44f0-9842-835438e2461a
Version: 1
Effective Time: 20130425
 
PuraVation Pharmaceuticals Inc

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer