Drugplain

Nighttime Sleep Aid 25 mg/1

Nighttime Sleep Aid · TABLET · Allegiant Health

2 Recalls on Record
Plain English

Nighttime Sleep Aid is a tablet containing nighttime sleep aid at 25 mg/1, taken oral. Manufactured by Allegiant Health.

Key Facts

Brand Name
Nighttime Sleep Aid
Generic Name
Nighttime Sleep Aid
NDC Code (Product)
69168-439
Manufacturer
Allegiant Health
Strength
25 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
ANDA040564
Marketing Start
05/16/2023

Recall History

2 Recalls on Record
Class II03/04/2025

Chattem Inc

CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug Administration.

OngoingVoluntary: Firm initiated
Class III08/04/2022

LNK International, Inc.

Labeling: Not Elsewhere Classified: Carton incorrectly identifies product as doxylamine succinate HCl, however the product is doxylamine succinate.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

fatigue4,098 reports
drug ineffective3,697 reports
pain3,581 reports
headache3,547 reports
off label use3,489 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 contains Nighttime Sleep Aid. It is a tablet taken oral. Consult your doctor for specific uses.

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 Nighttime Sleep Aid. There are no other listed brand versions of Nighttime Sleep Aid.

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 69168-439, listed by Allegiant Health.

Product NDC

69168-439

Package NDC

69168-439-06

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

Data from openFDA · Public domain (CC0 1.0)