Drug Facts

Drug Facts

SPL v2

SPL

SPL Set ID a23b5195-518e-4093-aea4-10ce96460ee2

Route

ORAL

Published

Effective Date 2019-04-12

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Diphenhydramine (25 mg)

Inactive Ingredients

Fd&c Red No. 3 Gelatin, Unspecified Lactose, Unspecified Form Magnesium Stearate Polyethylene Glycol 8000 Silicon Dioxide Talc

Identifiers & Packaging

Pill Appearance

Imprint: Dormin;25mg Shape: capsule Color: pink Size: 16 mm Score: 1

Marketing Status

OTC MONOGRAPH FINAL Active Since 1992-01-01

Description

Diphenhydramine Hydrochloride

Medication Information

Description

Diphenhydramine Hydrochloride

Uses

▪
helps to reduce difficulty falling asleep

Stop Use

Stop use and ask a doctor if sleeplessness lasts for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

Warnings

▪
Do not use
▪
in children under 12 years of age
▪
with any other product containing diphenhydramine, even one used on skin

Ask Doctor

As a doctor before use if you have

▪
a breathing problem such as emphysema or chronic bronchitis
▪
glaucoma
▪
trouble urinating due to enlarged prostate gland

Directions

Adult and children 12 years and over: Take 2 capsules (50 mg) at bedtime if needed or as directed by a doctor

Children under 12 years of age: Do not give this product to children under 12 years of age

When Using

When using this product

▪
avoid alcoholic drinks

Active Ingredient

Diphenhydramine Hydrochloride

Other Information

▪
keep in dry place

Use by expiration date on pack

Inactive Ingredients

FD&C Red No. 3, Gelatin, Lactose, Magnesium Stearate, Polyethylene Glycol, Silicon Dioxide, Talc.

Ask Doctor/pharmacist

As a doctor or pharmacist before use if you are taking sedatives or tranquilizers

Principal Display Panel

Dormin®

THE NIGHTTIME SLEEP-AID

With Diphenhydramine Hydrochloride

•
FAST
•
SAFE
•
EFFECTIVE

72 Capsules

Pregnancy 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.

Structured Label Content

Uses

▪
helps to reduce difficulty falling asleep

Stop Use

Stop use and ask a doctor if sleeplessness lasts for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

Warnings

▪
Do not use
▪
in children under 12 years of age
▪
with any other product containing diphenhydramine, even one used on skin

Ask Doctor

As a doctor before use if you have

▪
a breathing problem such as emphysema or chronic bronchitis
▪
glaucoma
▪
trouble urinating due to enlarged prostate gland

Directions

Adult and children 12 years and over: Take 2 capsules (50 mg) at bedtime if needed or as directed by a doctor

Children under 12 years of age: Do not give this product to children under 12 years of age

When Using

When using this product

▪
avoid alcoholic drinks

Active Ingredient (Active ingredient)

Diphenhydramine Hydrochloride

Other Information

▪
keep in dry place

Use by expiration date on pack

Inactive Ingredients

FD&C Red No. 3, Gelatin, Lactose, Magnesium Stearate, Polyethylene Glycol, Silicon Dioxide, Talc.

Ask Doctor/pharmacist (Ask Doctor/Pharmacist)

As a doctor or pharmacist before use if you are taking sedatives or tranquilizers

Principal Display Panel

Dormin®

THE NIGHTTIME SLEEP-AID

With Diphenhydramine Hydrochloride

•
FAST
•
SAFE
•
EFFECTIVE

72 Capsules

Pregnancy Or Breast Feeding (Pregnancy 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.

Advanced Ingredient Data

[{"name": "DIPHENHYDRAMINE", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "25", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "FD&C RED NO. 3", "unii": "PN2ZH5LOQY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GELATIN, UNSPECIFIED", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LACTOSE, UNSPECIFIED FORM", "unii": "J2B2A4N98G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL 8000", "unii": "Q662QK8M3B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TALC", "unii": "7SEV7J4R1U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "▪ helps to reduce difficulty falling asleep", "Stop Use": "Stop use and ask a doctor if sleeplessness lasts for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.", "Warnings": "▪ Do not use ▪ in children under 12 years of age ▪ with any other product containing diphenhydramine, even one used on skin", "Ask Doctor": "As a doctor before use if you have ▪ a breathing problem such as emphysema or chronic bronchitis ▪ glaucoma ▪ trouble urinating due to enlarged prostate gland", "Directions": "Adult and children 12 years and over: Take 2 capsules (50 mg) at bedtime if needed or as directed by a doctor Children under 12 years of age: Do not give this product to children under 12 years of age", "When Using": "When using this product ▪ avoid alcoholic drinks", "Active ingredient": "Diphenhydramine Hydrochloride", "Other Information": "▪ keep in dry place Use by expiration date on pack", "Inactive Ingredients": "FD&C Red No. 3, Gelatin, Lactose, Magnesium Stearate, Polyethylene Glycol, Silicon Dioxide, Talc.", "Ask Doctor/Pharmacist": "As a doctor or pharmacist before use if you are taking sedatives or tranquilizers", "Principal Display Panel": "Dormin® THE NIGHTTIME SLEEP-AID With Diphenhydramine Hydrochloride • FAST • SAFE • EFFECTIVE 72 Capsules", "Pregnancy 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."}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:56:47.770918 · Updated: 2026-03-14T22:55:31.631898