NIGHTTIME SLEEPAID- diphenhydramine hydrochloride capsule, gelatin coated

Nighttime Sleepaid by

Drug Labeling and Warnings

Nighttime Sleepaid by is a Otc medication manufactured, distributed, or labeled by Kareway Product, Inc., DongKoo Pharm. Ind. Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients (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.(1-800-222-1222)

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 bed time if needed or as directed by a doctor

Other information

• store at 20-25° C (68-77° F)
• avoid excessive heat above 40° C (104° F) and high humidity
• Protect from light

Inactive ingredients

FD&C blue No.1, FD&C Rd No. 40, gelatin, glycerin, polyethylene glycol 400, partially hydrated sorbitol liquid, purified water

SPL UNCLASSIFIED SECTION

Exclusively distributed by:

Kareway Product, Inc.

2550 S. Dominguez Hills Dr.

Compton, CA  90220

Made in Korea

PRINCIPAL DISPLAY PANEL - 12 Capsule Carton

INGREDIENTS AND APPEARANCE

NIGHTTIME SLEEPAID 
diphenhydramine hydrochloride capsule, gelatin coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67510-0557
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  in 2

Inactive Ingredients
Ingredient Name	Strength
FD&C Blue No. 1 (UNII: H3R47K3TBD)
gelatin (UNII: 2G86QN327L)
glycerin (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
water (UNII: 059QF0KO0R)
FD&C Red No. 40 (UNII: WZB9127XOA)
sorbitol (UNII: 506T60A25R)

Product Characteristics
Color	PURPLE	Score	no score
Shape	CAPSULE	Size	15mm
Flavor		Imprint Code	SLAD
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67510-0557-1	12 in 1 CARTON
1		2 in 1 BLISTER PACK
2	NDC: 67510-0557-2	24 in 1 CARTON
2		2 in 1 BLISTER PACK
3	NDC: 67510-0557-3	36 in 1 CARTON
3		2 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part338	10/22/2014

Labeler - Kareway Product, Inc. (121840057)

Establishment
Name	Address	ID/FEI	Business Operations
DongKoo Pharm. Ind. Co., Ltd.		688235474	manufacture(67510-0557)