SLEEP AID- diphenhydramine hydrochloride 25 mg capsule, liquid filled 
PuraVation Pharmaceuticals 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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SLEEP AID (Diphenhydramine 25 mg) capsule, liquid filled

Drug Facts

Active ingredient (in each softgel)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Uses

  • for the relief of occasional sleeplessness
  • reduces time to fall asleep if you have 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
  • with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products

Ask a doctor before use if you have

  • a breathing problem such as asthma, emphysema, or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland
  • heart disease

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers or any other sleep aid

When using this product

  • avoid alcoholic beverages and other drugs that cause drowsiness
  • drowsiness will occur
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if sleeplessness persists 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. Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • take only one dose per day (24 hours) -  see Overdose warning

adults & children

12 yrs & over

                     One dose = TWO 25 mg softgels (50 mg)

                     at bedtime if needed or as directed by a doctor

Other information

  • store at room temperature 15°-30°C (59°-86°F)
  • avoid excessive heat above 40°C (104°F) and high humidity
  • protect from light

Inactive ingredients

FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol, purified water, sorbitol special and white edible ink

PRINCIPAL DISPLAY PANEL

Sleep Aid

NIGHTTIME

NDC 76270-150-02

*Compare to the active ingredient in ZzzQuil®

DIPHENHYDRAMINE HCl 25 mg EACH

Non Habit-Forming

Not for Treating Cold or Flu

See Warnings

12 LIQUID-DILLED SOFTGELS

PRINCIPAL DISPLAY PANEL - Shipping Label

SLEEP AID 
diphenhydramine hydrochloride 25 mg capsule, liquid filled
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:76270-150
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
Color purple Score no score
Shape CAPSULE (OBLONG) Size 15mm
Flavor Imprint Code PC11
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:76270-150-02 1 in 1 CARTON 04/15/2013 12/30/2016
1 12 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 04/15/2013 12/30/2016
Labeler - PuraVation Pharmaceuticals Inc (968385034)
Establishment
Name Address ID/FEI Business Operations
Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. 421293287 MANUFACTURE(76270-150) , ANALYSIS(76270-150)

Revised: 12/2016
PuraVation Pharmaceuticals Inc