Drugplain

Nighttime Sleep Aid 25 mg/1

Doxylamine Succinate · TABLET · Amerisource Bergen

No Recall History
Plain English

Nighttime Sleep Aid containing doxylamine succinate is an over-the-counter oral tablet used to help people fall asleep. This medication is an antihistamine that works by causing drowsiness to aid sleep onset.

Key Facts

Brand Name
Nighttime Sleep Aid
Generic Name
Doxylamine Succinate
NDC Code (Product)
46122-788
Manufacturer
Amerisource Bergen
Strength
25 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
ANDA040564
Marketing Start
06/07/2024

Recall History

No Recall History

Side Effects Reported to FDA

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

fatigue4,100 reports
drug ineffective3,697 reports
pain3,582 reports
headache3,548 reports
off label use3,491 reports
nausea3,237 reports
infusion related reaction3,230 reports
arthralgia3,150 reports
pneumonia2,656 reports
nasopharyngitis2,603 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses for the relief of occasional sleeplessness reduces time to fall asleep if you have difficulty falling asleep

Dosage & Administration

Directions take only one dose (30 mL) per day (24 hours) only use dose cup provided adults & children 12 yrs & over 30 mL at bedtime if needed or as directed by a doctor children under 12 yrs do not use

Warnings

Warnings Do not use for children under 12 years of age with any other product containing diphenhydramine, even one used on skin

Frequently Asked Questions

What is Nighttime Sleep Aid used for?

Nighttime Sleep Aid containing doxylamine succinate is an over-the-counter oral tablet used to help people fall asleep. This medication is an antihistamine that works by causing drowsiness to aid sleep onset.

Is Nighttime Sleep Aid a controlled substance?

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

What is the generic name for Nighttime Sleep Aid?

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

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

The NDC (National Drug Code) for Nighttime Sleep Aid 25 mg/1 is 46122-788, listed by Amerisource Bergen.

Product NDC

46122-788

Package NDC

46122-788-15

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)