Topcare® health Nighttime Maximum Strength Sleep Aid

SPL v2

SPL

SPL Set ID 2ea0b2cf-f055-11f6-e063-6394a90a5364

Route

ORAL

Published

Effective Date 2025-08-05

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (50 mg)

Inactive Ingredients

Fd&c Blue No. 1 Gelatin, Unspecified Glycerin Polyethylene Glycol 400 Propylene Glycol Sorbitol Sorbitan Titanium Dioxide

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-08-01

Description

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid

Medication Information

Purpose

Nighttime sleep-aid

Description

Diphenhydramine HCl 50 mg

Use

• for relief of occasional sleeplessness

Section 42229-5

®COMPARE TO UNISOM^®SLEEPGELS^®ACTIVE INGREDIENT*

• Fall Asleep Fast

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

DISTRIBUTED BY

TOPCO ASSOCIATES LLC

ITASCA, IL 60143

©TOPCO STVA0425

[email protected]

www.topcarebrand.com

PRODUCT OF INDIA

*This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Unisom^®.

QUALITY GUARANTEED

This TopCare^® product is laboratory tested to guarantee its highest quality. Your total satisfaction is guaranteed.

Section 50565-1

Keep out of reach of children. Overdose warning:

In case of overdose, get medical help or contact a Poison Control Center right away.

Warnings

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

• trouble urinating due to an enlarged prostate gland

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

When using this product avoid alcoholic drinks

Stop use and ask a doctor if sleeplessness persist 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.

Packaging

Directions

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

Questions?

Call toll-free: 1-888-423-0139

Other Information

• store at controlled room temperature 20–25°C (68–77°F)

Inactive Ingredients

FD&C blue No. 1, gelatin, glycerin, polyethylene glycol 400, propylene glycol, sorbitol sorbitan anhydrous, titanium dioxide

Active Ingredient (in Each Softgel)

Diphenhydramine HCl 50 mg

Structured Label Content

Use

• for relief of occasional sleeplessness

Section 42229-5 (42229-5)

®COMPARE TO UNISOM^®SLEEPGELS^®ACTIVE INGREDIENT*

• Fall Asleep Fast

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

DISTRIBUTED BY

TOPCO ASSOCIATES LLC

ITASCA, IL 60143

©TOPCO STVA0425

[email protected]

www.topcarebrand.com

PRODUCT OF INDIA

*This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Unisom^®.

QUALITY GUARANTEED

This TopCare^® product is laboratory tested to guarantee its highest quality. Your total satisfaction is guaranteed.

Section 50565-1 (50565-1)

Keep out of reach of children. Overdose warning:

In case of overdose, get medical help or contact a Poison Control Center right away.

Purpose

Nighttime sleep-aid

Warnings

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

• trouble urinating due to an enlarged prostate gland

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

When using this product avoid alcoholic drinks

Stop use and ask a doctor if sleeplessness persist 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.

Packaging

Directions

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

Questions?

Call toll-free: 1-888-423-0139

Other Information (Other information)

• store at controlled room temperature 20–25°C (68–77°F)

Inactive Ingredients (Inactive ingredients)

FD&C blue No. 1, gelatin, glycerin, polyethylene glycol 400, propylene glycol, sorbitol sorbitan anhydrous, titanium dioxide

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

Diphenhydramine HCl 50 mg

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Use": "• for relief of occasional sleeplessness", "42229-5": "®COMPARE TO UNISOM ® SLEEPGELS ® ACTIVE INGREDIENT* • Fall Asleep Fast TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING DISTRIBUTED BY TOPCO ASSOCIATES LLC ITASCA, IL 60143 ©TOPCO STVA0425 topcare@topco.com www.topcarebrand.com PRODUCT OF INDIA *This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Unisom ® . QUALITY GUARANTEED This TopCare ® product is laboratory tested to guarantee its highest quality. Your total satisfaction is guaranteed.", "50565-1": "Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away.", "Purpose": "Nighttime sleep-aid", "Warnings": "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 • trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product avoid alcoholic drinks Stop use and ask a doctor if sleeplessness persist 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.", "Directions": "• adults and children 12 years of age and over: 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor", "Questions?": "Call toll-free: 1-888-423-0139", "Other information": "• store at controlled room temperature 20–25°C (68–77°F)", "Inactive ingredients": "FD&C blue No. 1, gelatin, glycerin, polyethylene glycol 400, propylene glycol, sorbitol sorbitan anhydrous, titanium dioxide", "Active ingredient (in each softgel)": "Diphenhydramine HCl 50 mg"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:06:42.397459 · Updated: 2026-03-14T23:09:37.690586