NIGHT TIME SLEEP AID- diphenhydramine hydrochloride capsule, liquid filled

Night Time Sleep Aid by

Drug Labeling and Warnings

Night Time Sleep Aid by is a Otc medication manufactured, distributed, or labeled by PuraCap Pharmaceutical LLC, Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

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 and children 12 years and over: ONE dose = TWO 25 mg softgels (50 mg) at bed time if needed or as directed by a doctor

Other Information

• store at 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

Questions or comments?

Call toll free 1-888-309-9030

PRINCIPAL DISPLAY PANEL - Carton Label

Night Time Sleep-Aid

Diphenhydramine HCl, 25 mg

Compare to the active ingredient of Vicks® ZzzQuil® LiquiCaps®*

12 Softgels

NDC: 51013-129-02

*This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® ZzzQuil® LiquiCaps®.

INGREDIENTS AND APPEARANCE

NIGHT TIME SLEEP AID 
diphenhydramine hydrochloride capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51013-129
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 GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	purple	Score	no score
Shape	capsule (oblong)	Size	14mm
Flavor		Imprint Code	PC11
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51013-129-02	1 in 1 CARTON	05/05/2016
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	part338	05/05/2016

Labeler - PuraCap Pharmaceutical LLC (962106329)

Establishment
Name	Address	ID/FEI	Business Operations
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd		421293287	manufacture(51013-129) , analysis(51013-129)