SLEEP AID- diphenhydramine hcl capsule

Sleep Aid by

Drug Labeling and Warnings

Sleep Aid by is a Otc medication manufactured, distributed, or labeled by Care One (American Sales Company). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each softgel)

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid

Use

for relief of occasional sleeplessness.

Warnings

Do not use

• for children under 12 years of age
• 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 persists continuously for more than 2 weeks. Insomnia may be a symptom of a 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. (1-800-222-1222)

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 15-30°C (59°-86°F)

Inactive ingredients

edible white ink, FD&C blue #1, gelatin, glycerin, polyethylene glycol, propylene glycol*, purified water, sorbitol, sorbitan*

*contain one or more of these ingredients

Principal Display Panel

Compare to the Active Ingredient in Unisom® SleepGels®†

Maximum Strength

SLEEP - AID

Diphenhydramine HCI 50 mg

Helps to Reduce Difficulty Falling Asleep

SOFTGELS**

**Liquid Filled Capsules

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

**This product is not manufactured or distributed by Chattem, Inc., distributor of Unisom® SleepGels®.

DISTRIBUTED BY FOODHOLD U.S.A., LLC LANDOVER, MD 20785

1-877-846-9949

Package Label

CAREONE Sleep-Aid Softgels

INGREDIENTS AND APPEARANCE

SLEEP AID 
diphenhydramine hcl capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41520-835
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)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
WATER (UNII: 059QF0KO0R)
SORBITAN (UNII: 6O92ICV9RU)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	BLUE	Score	no score
Shape	CAPSULE	Size	13mm
Flavor		Imprint Code	P50;A99;D50;AP018
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41520-835-32	1 in 1 BOX	09/30/2018
1		32 in 1 BOTTLE, PLASTIC; 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	09/30/2018

Labeler - Care One (American Sales Company) (809183973)