Nighttime Sleep-aid

Nighttime Sleep-aid
SPL v1
SPL
SPL Set ID 357e6165-6ffe-b05f-e063-6394a90a4ef6
Route
ORAL
Published
Effective Date 2024-11-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Gelatin, Unspecified Glycerin Polyethylene Glycol, Unspecified Water Sorbitol

Identifiers & Packaging

Pill Appearance
Imprint: S25 Shape: capsule Color: white Size: 6 mm
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-16
Description

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Medication Information

Purpose

Nighttime sleep-aid

Description

Diphenhydramine HCl 25 mg

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

Directions
  • take only one dose per day (24 hours)- see overdose warning
  • adults & children 12 yrs & over

2 25mg softgels(50mg) at bedtime if needed or as directed by a doctor
  • children under 12 yrs

do not use
Do Not Use
  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
Questions ?

1-888-547-5492

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

When Using This Product
  • avoid alcoholic beverages
Other Information Storage

Store at no greater than 25 degree C

avoid excessive heat above 40 degree C

protect from light

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

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).

Active Ingredient (in Each Softgel)

Diphenhydramine HCl 25 mg

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
Package/label Principal Display Panel

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers

Structured Label Content

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

Nighttime sleep-aid

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

Directions
  • take only one dose per day (24 hours)- see overdose warning
  • adults & children 12 yrs & over

2 25mg softgels(50mg) at bedtime if needed or as directed by a doctor
  • children under 12 yrs

do not use
Do Not Use (Do not use)
  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
Questions ?

1-888-547-5492

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

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

Questions Or Comments? (Questions or comments?)

1-800-719-9260

When Using This Product (When using this product)
  • avoid alcoholic beverages
Other Information Storage (Other Information- Storage)

Store at no greater than 25 degree C

avoid excessive heat above 40 degree C

protect from light

Stop Use and Ask A Doctor If (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 (if pregnant or breast feeding)

ask a health professional before use

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (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).

Active Ingredient (in Each Softgel) (Active ingredient (in each softgel))

Diphenhydramine HCl 25 mg

Ask A Doctor Before Use If You Have (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
Package/label Principal Display Panel (Package/Label Principal Display Panel)

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:06:09.296309 · Updated: 2026-03-14T23:08:46.104923