Nighttime Sleep-Aid 50 mg/1
Diphenhydramine HCl · CAPSULE, LIQUID FILLED · AMERISOURCE BERGEN
Diphenhydramine HCl is an over-the-counter antihistamine used to help people fall asleep at night. It comes as an oral capsule containing 50 mg of the active ingredient.
Key Facts
- Brand Name
- Nighttime Sleep-Aid
- Generic Name
- Diphenhydramine HCl
- NDC Code (Product)
46122-775- Manufacturer
- AMERISOURCE BERGEN
- Strength
- 50 mg/1
- Dosage Form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Marketing Status
- Application #
- M010
- Marketing Start
- 04/11/2024
Recall History
Chattem Inc
CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug Administration.
LNK International, Inc.
Labeling: Not Elsewhere Classified: Carton incorrectly identifies product as doxylamine succinate HCl, however the product is doxylamine succinate.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
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?
Diphenhydramine HCl is an over-the-counter antihistamine used to help people fall asleep at night. It comes as an oral capsule containing 50 mg of the active ingredient.
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 Diphenhydramine HCl. There are 12 other brand versions of Diphenhydramine HCl.
What is the NDC code for Nighttime Sleep-Aid 50 mg/1?
The NDC (National Drug Code) for Nighttime Sleep-Aid 50 mg/1 is 46122-775, listed by AMERISOURCE BERGEN.
Other Diphenhydramine Brands
See all →- Dr Kids Allergy Relief12.5 mg/5mL73282-2521
- ADVIL PM25 mg/10573-0148
- Diphenhydramine HCl Oral Solution12.5 mg/5mL81033-029
- Itch Relief20 mg/mL81522-751
- Kosher Meds Childrens Allergy Relief12.5 mg/5mL82179-004
- GOODNOW SLEEP AID50 mg/30mL82501-0186
- Nighttime Cold and Cough12.5 mg/5mL82673-191
- Quality Choice Dye Free Cherry Childrens Allergy Relief12.5 mg/5mL83324-016
- Sleep Aid25 mg/184324-016
- OneSsip Diphenhydramine HCl 12.5 mg/ 5 mL Oral Solution12.5 mg/5mL87078-411
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)