Drugplain

TopCare Sleep Aid 25 mg/1

Doxylamine succinate · TABLET · Topco Associates LLC

No Recall History
Plain English

TopCare Sleep Aid is a tablet containing doxylamine succinate at 25 mg/1, taken oral. Manufactured by Topco Associates LLC.

Key Facts

Brand Name
TopCare Sleep Aid
Generic Name
Doxylamine succinate
NDC Code (Product)
36800-441
Manufacturer
Topco Associates LLC
Strength
25 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
ANDA040167
Marketing Start
01/29/1997

Recall History

No Recall History

Side Effects Reported to FDA

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

fatigue3,582 reports
drug ineffective3,277 reports
off label use3,196 reports
headache3,164 reports
pain3,133 reports
infusion related reaction2,772 reports
nausea2,728 reports
arthralgia2,720 reports
nasopharyngitis2,394 reports
pneumonia2,339 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Use • helps to reduce difficulty in falling asleep

Dosage & Administration

Directions • adults and children 12 years of age and over: take one tablet 30 minutes before going to bed; take once daily or as directed by a doctor • children under 12 years of age: do not use

Warnings

Warnings Do not use • in children under 12 years of age • with any other product containing doxylamine • unless you have time for a full night’s sleep 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 • a sedative or any other sleep-aid • tranquilizers • any other antihistamines • any other drugs When using this product • avoid alcoholic beverages • do not drive a motor vehicle or operate machinery • take only at bedtime Stop use and ask a doctor if • sleeplessness persists continuously for more than two 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. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Frequently Asked Questions

What is TopCare Sleep Aid used for?

TopCare Sleep Aid contains Doxylamine succinate. It is a tablet taken oral. Consult your doctor for specific uses.

Is TopCare Sleep Aid a controlled substance?

TopCare Sleep Aid is not classified as a controlled substance by the DEA.

What is the generic name for TopCare Sleep Aid?

The generic name for TopCare Sleep Aid is Doxylamine succinate. There are 11 other brand versions of Doxylamine succinate.

What is the NDC code for TopCare Sleep Aid 25 mg/1?

The NDC (National Drug Code) for TopCare Sleep Aid 25 mg/1 is 36800-441, listed by Topco Associates LLC.

Product NDC

36800-441

Package NDC

36800-441-64

Other Doxylamine 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)