Drugplain

TopCare health NIGHTTIME MAXIMUM STRENGTH Sleep Aid 50 mg/1

Diphenhydramine hydrochloride · CAPSULE, LIQUID FILLED · Topco Associates LLC

No Recall History
Plain English

TopCare health NIGHTTIME MAXIMUM STRENGTH Sleep Aid is a capsule, liquid filled containing diphenhydramine hydrochloride at 50 mg/1, taken oral. Manufactured by Topco Associates LLC.

Key Facts

Brand Name
TopCare health NIGHTTIME MAXIMUM STRENGTH Sleep Aid
Generic Name
Diphenhydramine hydrochloride
NDC Code (Product)
76162-438
Manufacturer
Topco Associates LLC
Strength
50 mg/1
Dosage Form
CAPSULE, LIQUID FILLED
Route
ORAL
Marketing Status
Application #
M010
Marketing Start
08/01/2025

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

fatigue3,476 reports
off label use3,144 reports
pain3,111 reports
headache3,110 reports
drug ineffective2,809 reports
infusion related reaction2,770 reports
arthralgia2,703 reports
nausea2,683 reports
nasopharyngitis2,384 reports
pneumonia2,296 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Use • for relief of occasional sleeplessness

Dosage & Administration

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

Warnings

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. Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away.

Frequently Asked Questions

What is TopCare health NIGHTTIME MAXIMUM STRENGTH Sleep Aid used for?

TopCare health NIGHTTIME MAXIMUM STRENGTH Sleep Aid contains Diphenhydramine hydrochloride. It is a capsule, liquid filled taken oral. Consult your doctor for specific uses.

Is TopCare health NIGHTTIME MAXIMUM STRENGTH Sleep Aid a controlled substance?

TopCare health NIGHTTIME MAXIMUM STRENGTH Sleep Aid is not classified as a controlled substance by the DEA.

What is the generic name for TopCare health NIGHTTIME MAXIMUM STRENGTH Sleep Aid?

The generic name for TopCare health NIGHTTIME MAXIMUM STRENGTH Sleep Aid is Diphenhydramine hydrochloride. There are 11 other brand versions of Diphenhydramine hydrochloride.

What is the NDC code for TopCare health NIGHTTIME MAXIMUM STRENGTH Sleep Aid 50 mg/1?

The NDC (National Drug Code) for TopCare health NIGHTTIME MAXIMUM STRENGTH Sleep Aid 50 mg/1 is 76162-438, listed by Topco Associates LLC.

Product NDC

76162-438

Package NDC

76162-438-96

Other Diphenhydramine Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)