SLEEP AID- diphenhydramine hydrochloride capsule, liquid filled

Sleep Aid by

Drug Labeling and Warnings

Sleep Aid by is a Otc medication manufactured, distributed, or labeled by Spirit Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient (in each tablet)

Diphenhydramine HCI 50 mg

Purpose

Nighttime sleep-aid

Uses

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 if you are

taking sedatives or tranquilizers

When using this product

avoid alcoholic drinks

Stop use and ask a doctor if

sleeplessness persist 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) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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 between 20–25°C (68–77°F)

Inactive ingredients

FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol 400, propylene glycol, sorbitol, titanium dioxide, water

Questions or comments?

1-888-333-9792

Distributed by:

Cabinet Health P.B.C.

Pouch

INGREDIENTS AND APPEARANCE

SLEEP AID 
diphenhydramine hydrochloride capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68210-4179
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 400 (UNII: B697894SGQ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	blue	Score	no score
Shape	OVAL	Size	13mm
Flavor		Imprint Code	903
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68210-4179-3	30 in 1 POUCH; Type 0: Not a Combination Product	11/22/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M010	11/21/2021

Labeler - Spirit Pharmaceuticals LLC (179621011)