NIGHTTIME SLEEP AID- diphenhydramine hydrochloride 50 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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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®

PRINCIPAL DISPLAY PANEL - Shipping Label

NIGHTTIME SLEEP AID
diphenhydramine hydrochloride 50 mg capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76270-109
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	50 mg

Ingredient Name	Strength
Inactive Ingredients
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	blue	Score	no score
Shape	CAPSULE (OVAL)	Size	13mm
Flavor		Imprint Code	PC5
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76270-109-16	1 in 1 CARTON	04/15/2013	12/30/2016
1		32 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC:76270-109-17	1 in 1 CARTON	04/15/2013	12/30/2016
2		64 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	04/15/2013	12/30/2016

Labeler - PuraVation Pharmaceuticals Inc (968385034)

Name	Address	ID/FEI	Business Operations
Establishment
Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.		421293287	MANUFACTURE(76270-109) , ANALYSIS(76270-109)

Revised: 12/2016

Document Id: 6080b6c6-0dd1-4c57-b62f-cafc881b9b2a

Set id: 4400053d-e06f-44f0-9842-835438e2461a

Version: 2

Effective Time: 20161230

PuraVation Pharmaceuticals Inc