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

Purpose

Nighttime sleep-aid

Description

Diphenhydramine HCl 50 mg

Medication Information

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.

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

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

Description

Diphenhydramine HCl 50 mg

Questions?

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

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.

Packaging

Active Ingredient (in Each Softgel)

Diphenhydramine HCl 50 mg

Structured Label Content

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.

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

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

Questions?

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

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.

Packaging

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

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