NIGHTTIME SLEEP AID- diphenhydramine hcl capsule, liquid filled

Nighttime sleep aid by

Drug Labeling and Warnings

Nighttime sleep aid by is a Otc medication manufactured, distributed, or labeled by ASCENT CONSUMER PRODUCTS, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each softgel)

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid

Uses

• for the relief of occasional sleeplessness
• reduces time to fall asleep if you have difficulty falling asleep

Warnings

Do not use

for children under 12 years if 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

difficulty in urniation due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

taking sedative or tranquilizers

When usiing this product avoid alcoholic beverages

Keep out of reach of children

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
• difficulty in urination due to an enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

When using this product

• avoid alcoholic beverages

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.

Ask a doctor or pharmacist before use if you are

taking sedative or tranquilizers

Ask a doctor before use if you have

a breathing problem such as emphysema or chronic bronchitis

glaucoma

difficulty in urination due to enlargement of the prostate gland

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

• take only one dose per day (24 hours)- see overdose warning

• adults & children 12 yrs & over:

  1 softgel(50mg) at bedtime if needed or as directed by a doctor

Other information

• store at 20-25 °C (68-77 °F)
• avoid excessive heat above 40 oC (104 oF)
• protect from light

Inactive ingredients

edible dye free ink, gelatin, glycerin, polyethylene glycol, purified water, sorbitol

Questions or comments?

1-800-719-9260

Questions ?

1-888-547-5492

Other Information- Storage

Store at no greater than 25 degree C

avoid excessive heat above 40 degree C

protect from light

Package/Label Principal Display Panel

INGREDIENTS AND APPEARANCE

NIGHTTIME SLEEP AID 
diphenhydramine hcl capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42829-950
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
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	white (Clear Transparent)	Score	score with uneven pieces
Shape	CAPSULE (Oval)	Size	7mm
Flavor		Imprint Code	S50
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42829-950-20	120 in 1 BOTTLE; Type 0: Not a Combination Product	05/16/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M010	05/16/2025

Labeler - ASCENT CONSUMER PRODUCTS, INC (078396381)