SLEEP AID capsule, liquid filled

Sleep Aid by

Drug Labeling and Warnings

Sleep Aid by is a Otc medication manufactured, distributed, or labeled by Good Sense. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient(s)

Diphenhydramine HCl 50mg

Purpose

Nighttime sleep aid

Use(s)

• for relief of occasional sleeplessness

Warnings

Do not use

• for children under 12 years of age
• with any other products containing diphenhydramine, even one used on skin  

Ask a doctor before use if

• 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 breastfeeding,

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 (1-800-222-1222) right away.

Directions

Adults and children 12 years and over: 1 softgel (50mg) at bedtime if needed, or as directed by a doctor

Other information

• store at room temperature 15° to 30°C (59° to 86°F)
• avoid excessive heat

Inactive ingredients

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

Questions/Comments

Call 1-888-952-0050 Monday through Friday 9AM – 5PM EST

Principal Display Panel

Sleep Aid

INGREDIENTS AND APPEARANCE

SLEEP AID 
sleep aid capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50804-410
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, UNSPECIFIED (UNII: 3WJQ0SDW1A)
WATER (UNII: 059QF0KO0R)
SORBITOL SOLUTION (UNII: 8KW3E207O2)

Product Characteristics
Color	blue	Score	no score
Shape	OVAL	Size	13mm
Flavor		Imprint Code	PC5
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50804-410-38	1 in 1 CARTON	06/18/2024
1		32 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 Drug	M010	06/18/2024

Labeler - Good Sense (076059836)