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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE)	DIPHENHYDRAMINE HYDROCHLORIDE	50 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1
GELATIN
GLYCERIN
POLYETHYLENE GLYCOLS
WATER
SORBITOL

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

Packaging
#	Item Code	Package Description
1	NDC:76270-109-16	1 BOTTLE, PLASTIC (BOTTLE) in 1 CARTON
1		32 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BOTTLE, PLASTIC
2	NDC:76270-109-17	1 BOTTLE, PLASTIC (BOTTLE) in 1 CARTON
2		64 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BOTTLE, PLASTIC

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

Labeler - PuraVation Pharmaceuticals Inc (968385034)

Establishment
Name	Address	ID/FEI	Operations
Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.		421293287	MANUFACTURE(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

NIGHTTIME SLEEP AID

Further information

See also:

Lybalvi

Vraylar

Ozempic

Abilify

Seroquel

Lamictal

Depakote

Lithium

Carbamazepine

Risperidone