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US · Over-the-counter medicine

Nighttime sleep aid

Dosage form
CAPSULE, LIQUID FILLED
Labeler
ASCENT CONSUMER PRODUCTS, INC
Label updated
2025-05-16
Retrieved
2026-09-07
Active ingredients
DIPHENHYDRAMINE HYDROCHLORIDE
View original label and images on DailyMed ↗
Active ingredient (in each softgel)

Diphenhydramine HCl 25 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
  1. adults & children 12 yrs & over

2 25mg softgels(50mg) at bedtime if needed or as directed by a doctor

  1. children under 12 yrs

do not use

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

[Image in the official label — see DailyMed source]

[Image in the official label — see DailyMed source]

DailyMed Set ID: 357e6165-6ffe-b05f-e063-6394a90a4ef6 · Version 1
NDC: 42829-925