Drugplain

Sleep Aid Nighttime 50 mg/1

Diphenhydramine Hydrochloride · CAPSULE, LIQUID FILLED · TOPCO ASSOCIATES LLC

No Recall History
Plain English

Sleep Aid Nighttime is a capsule, liquid filled containing diphenhydramine hydrochloride at 50 mg/1, taken oral. Manufactured by TOPCO ASSOCIATES LLC.

Key Facts

Brand Name
Sleep Aid Nighttime
Generic Name
Diphenhydramine Hydrochloride
NDC Code (Product)
36800-784
Manufacturer
TOPCO ASSOCIATES LLC
Strength
50 mg/1
Dosage Form
CAPSULE, LIQUID FILLED
Route
ORAL
Marketing Status
Application #
M010
Marketing Start
05/01/2021

Recall History

No Recall History

Side Effects Reported to FDA

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

fatigue3,945 reports
pain3,521 reports
headache3,486 reports
off label use3,410 reports
infusion related reaction3,221 reports
drug ineffective3,169 reports
nausea3,159 reports
arthralgia3,109 reports
pneumonia2,594 reports
nasopharyngitis2,591 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 persists continuously for more than 2 weeks. Insomnia may be a symptom of a 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 (1-800-222-1222) right away

Frequently Asked Questions

What is Sleep Aid Nighttime used for?

Sleep Aid Nighttime contains Diphenhydramine Hydrochloride. It is a capsule, liquid filled taken oral. Consult your doctor for specific uses.

Is Sleep Aid Nighttime a controlled substance?

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

What is the generic name for Sleep Aid Nighttime?

The generic name for Sleep Aid Nighttime is Diphenhydramine Hydrochloride. There are 12 other brand versions of Diphenhydramine Hydrochloride.

What is the NDC code for Sleep Aid Nighttime 50 mg/1?

The NDC (National Drug Code) for Sleep Aid Nighttime 50 mg/1 is 36800-784, listed by TOPCO ASSOCIATES LLC.

Product NDC

36800-784

Package NDC

36800-784-96

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)