PREMIER VALUE SLEEP-AID- diphenhydramine hcl capsule

Premier Value Sleep-Aid by

Drug Labeling and Warnings

Premier Value Sleep-Aid by is a Otc medication manufactured, distributed, or labeled by Chain Drug Consortium LLC, Marksans Pharma Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT(S)

Diphenhydramine HCl 50 mg

PURPOSE

Nighttime sleep- aid

USE(S)

• helps to reduce difficulty falling asleep

WARNINGS

Do not give to children under 12 years of age.

DO NOT USE

• With other products containing diphenhydramine, even one used on skin.

ASK A DOCTOR BEFORE USE IF

• emphysema
• chronic bronchitis
• glaucoma
• difficulty in urination due to an enlargement of the prostate gland

ASK A DOCTOR OR PHARMACIST BEFORE USE IF

Sedatives or tranquilizers

WHEN USING THIS PRODUCT

Avoid alcoholic beverages

STOP USE AND ASK DOCTOR IF

•  Sleeplessness persists for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.

PREGNANCY/BREASTFEEDING

Ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

In case of accidental overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

DIRECTIONS

• adults and children 12 years of age and over: take 1 softgel at bedtime if needed or as directed by a doctor

STORAGE

• Store at controlled room temperature 15°-30°C (59°-86°F)
• do not use if imprinted safety seal under cap is broken or missing
• *This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Maximum Strength Unisom SleepGels®

INACTIVE INGREDIENTS

Gelatin, Sorbitol, Sorbitan, FD&C Blue No. 1, Water, Polyethylene Glycol 400, Povidone K-30

PRINCIPAL DISPLAY PANEL

Carton Label PDP

NDC # 68016-302-32

Sleep-Aid
DIPHENHYDRAMINE HCL 50 mg

GET TO SLEEP FAST
SLEEP SOUNDLY
WAKE REFRESHED

32 Softgels








Bottle Label PDP

NDC # 68016-302-32

Sleep-Aid
DIPHENHYDRAMINE HCL 50 mg

GET TO SLEEP FAST
SLEEP SOUNDLY
WAKE REFRESHED

32 Softgels

INGREDIENTS AND APPEARANCE

PREMIER VALUE SLEEP-AID 
diphenhydramine hcl capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68016-302
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN (UNII: 2G86QN327L)
WATER (UNII: 059QF0KO0R)
SORBITAN (UNII: 6O92ICV9RU)
SORBITOL (UNII: 506T60A25R)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POVIDONE K30 (UNII: U725QWY32X)

Product Characteristics
Color	BLUE	Score	no score
Shape	CAPSULE	Size	13mm
Flavor		Imprint Code	22
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68016-302-32	1 in 1 CARTON
1		32 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	05/31/2013

Labeler - Chain Drug Consortium LLC (101668460)

Registrant - Chain Drug Consortium LLC (101668460)

Establishment
Name	Address	ID/FEI	Business Operations
Marksans Pharma Limited		925822975	MANUFACTURE(68016-302)