BASIC CARE NIGHTTIME SLEEP AID- diphenhydramine hcl capsule, liquid filled

basic care nighttime sleep aid by

Drug Labeling and Warnings

basic care nighttime sleep aid by is a Otc medication manufactured, distributed, or labeled by L. Perrigo 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 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 20-25°C (68-77°F)

Inactive ingredients

edible ink*, FD&C blue #1, gelatin, glycerin, polyethylene glycol, purified water, sorbitol sorbitan solution *may contain this ingredient

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

Compare to Unisom® SleepGels® active ingredient

Non-Habit Forming

nighttime sleep-aid

Diphenhydramine HCl Softgels, 50 mg

actual size

One softgel per dose

96 SOFTGELS

INGREDIENTS AND APPEARANCE

BASIC CARE NIGHTTIME SLEEP AID 
diphenhydramine hcl capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0113-7506
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)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	BLUE (clear to light blue)	Score	no score
Shape	ROUND	Size	13mm
Flavor		Imprint Code	5V6
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0113-7506-80	1 in 1 CARTON	08/15/2019
1		96 in 1 BOTTLE; 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	08/15/2019

Labeler - L. Perrigo Company (006013346)