Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (50 mg)

Inactive Ingredients

Fd&c Blue No. 1 Gelatin Glycerin Polyethylene Glycol, Unspecified Water Sorbitan Sorbitol

Identifiers & Packaging

Pill Appearance

Imprint: P50 Shape: capsule Color: blue Size: 13 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2019-12-27

Medication Information

Purpose

Nighttime sleep-aid

Description

Diphenhydramine HCl 50 mg

Use

for relief of occasional sleeplessness.

Directions

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

Do Not Use

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

Package Label

Nighttime Sleep Aid Diphenhydramine HCl 50 mg

Other Information

store at 15-30°C (59°-86°F)

Inactive Ingredients

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

Principal Display Panel

Compare to the Active Ingredient in Unisom® SleepGels®†

Maximum Strength

NIGHTIME SLEEP - AID

Diphenhydramine HCL, 50 mg

Helps to Reduce Difficulty Falling Asleep

SOFTGELS**

**Liquid Filled Capsules

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

†This product is not manufactured or distributed by Sanofi Consumer Healthcare NA, distributor of Unisom® SleepGels®.

DISTRIBUTED BY ADUSA DISTRIBUTION, LLC

SALISBURY, NC 28147

contact us at 1-833-992-3872

Quality guaranteed or your money back.

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

Active Ingredient (in Each Softgel)

Diphenhydramine HCl 50 mg

Ask A Doctor Before Use If You Have

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.

Structured Label Content

Use

for relief of occasional sleeplessness.

Purpose

Nighttime sleep-aid

Directions

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

Do Not Use (Do not use)

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

Package Label

Nighttime Sleep Aid Diphenhydramine HCl 50 mg

Other Information (Other information)

store at 15-30°C (59°-86°F)

Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel

Compare to the Active Ingredient in Unisom® SleepGels®†

Maximum Strength

NIGHTIME SLEEP - AID

Diphenhydramine HCL, 50 mg

Helps to Reduce Difficulty Falling Asleep

SOFTGELS**

**Liquid Filled Capsules

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

†This product is not manufactured or distributed by Sanofi Consumer Healthcare NA, distributor of Unisom® SleepGels®.

DISTRIBUTED BY ADUSA DISTRIBUTION, LLC

SALISBURY, NC 28147

contact us at 1-833-992-3872

Quality guaranteed or your money back.

When Using This Product (When using this product)

avoid alcoholic drinks.

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 a serious underlying medical illness.

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

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

Diphenhydramine HCl 50 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
trouble urinating due to an enlarged prostate gland

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

[{"name": "DIPHENHYDRAMINE", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "50", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GELATIN", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITAN", "unii": "6O92ICV9RU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "for relief of occasional sleeplessness.", "Purpose": "Nighttime sleep-aid", "Directions": "adults and children 12 years of age and over: 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor", "Do not use": "for children under 12 years of age with any other product containing diphenhydramine, even one used on skin", "Package Label": "Nighttime Sleep Aid Diphenhydramine HCl 50 mg", "Other information": "store at 15-30°C (59°-86°F)", "Inactive ingredients": "FD&C blue #1, gelatin, glycerin, polyethylene glycol, purified water, sorbitol, sorbitan", "Principal Display Panel": "Compare to the Active Ingredient in Unisom® SleepGels®† Maximum Strength NIGHTIME SLEEP - AID Diphenhydramine HCL, 50 mg Helps to Reduce Difficulty Falling Asleep SOFTGELS** **Liquid Filled Capsules TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. †This product is not manufactured or distributed by Sanofi Consumer Healthcare NA, distributor of Unisom® SleepGels®. DISTRIBUTED BY ADUSA DISTRIBUTION, LLC SALISBURY, NC 28147 contact us at 1-833-992-3872 Quality guaranteed or your money back.", "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 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 (1-800-222-1222) right away.", "Active ingredient (in each softgel)": "Diphenhydramine HCl 50 mg", "Ask a doctor before use if you have": "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."}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information