BASIC CARE NIGHTTIME SLEEP AID- diphenhydramine hcl capsule, liquid filled
L. Perrigo Company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Amazon Nighttime Sleep-Aid Drug Facts

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

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

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

Ingredient Name	Strength
Inactive Ingredients
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0113-7506-80	1 in 1 CARTON	08/15/2019	05/31/2022
1		96 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part338	08/15/2019	05/31/2022

Labeler - L. Perrigo Company (006013346)

Revised: 11/2022

Document Id: b172f3d0-0125-4fad-88a3-db2b3ca87191

Set id: 806e60c7-b422-4511-a36a-7cb9d742e0b8

Version: 2

Effective Time: 20221116

L. Perrigo Company