Drugplain

topcare sleep aid nighttime 25 mg/1

Diphenhydramine Hydrochloride · TABLET, FILM COATED · Topco Associates LLC

No Recall History
Plain English

topcare sleep aid nighttime is a tablet, film coated containing diphenhydramine hydrochloride at 25 mg/1, taken oral. Manufactured by Topco Associates LLC.

Key Facts

Brand Name
topcare sleep aid nighttime
Generic Name
Diphenhydramine Hydrochloride
NDC Code (Product)
36800-431
Manufacturer
Topco Associates LLC
Strength
25 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
M010
Marketing Start
09/11/2001

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 and over take 2 caplets at bedtime if needed, or as directed by a doctor children under 12 years do not use

Warnings

Warnings Do not use • in 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 • drowsiness may occur • do not drive a motor vehicle or operate machinery Stop use and ask a doctor if • sleeplessness persists 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 (1-800-222-2222).

Frequently Asked Questions

What is topcare sleep aid nighttime used for?

topcare sleep aid nighttime contains Diphenhydramine Hydrochloride. It is a tablet, film coated taken oral. Consult your doctor for specific uses.

Is topcare sleep aid nighttime a controlled substance?

topcare sleep aid nighttime is not classified as a controlled substance by the DEA.

What is the generic name for topcare sleep aid nighttime?

The generic name for topcare sleep aid nighttime is Diphenhydramine Hydrochloride. There are 12 other brand versions of Diphenhydramine Hydrochloride.

What is the NDC code for topcare sleep aid nighttime 25 mg/1?

The NDC (National Drug Code) for topcare sleep aid nighttime 25 mg/1 is 36800-431, listed by Topco Associates LLC.