Sleep Aid 25 mg/1
diphenhydramine hydrochloride · TABLET, FILM COATED · Velocity Pharma LLC
Diphenhydramine hydrochloride is an over-the-counter antihistamine commonly used to help people fall asleep and stay asleep. This medication works by causing drowsiness and is available as a 25 mg coated tablet taken by mouth.
Key Facts
- Brand Name
- Sleep Aid
- Generic Name
- diphenhydramine hydrochloride
- NDC Code (Product)
76168-015- Manufacturer
- Velocity Pharma LLC
- Strength
- 25 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- part338
- Marketing Start
- 05/14/2018
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.
Ultra Seal Corporation
cGMP deviations
LNK International, Inc.
Labeling: Not Elsewhere Classified: Carton incorrectly identifies product as doxylamine succinate HCl, however the product is doxylamine succinate.
Ultra Seal Corporation
cGMP deviations
Ultra Seal Corporation
cGMP deviations
King Bio Inc.
Microbial contamination
Family Dollar Stores, Llc.
CGMP Deviations: product held outside appropriate storage temperature conditions.
King Bio Inc.
Microbial contamination
King Bio Inc.
Microbial contamination
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
Use helps to reduce difficulty in falling asleep
Dosage & Administration
Directions adults and children 12 years of age and over: take one tablet 30 minutes before going to bed; take once daily or as directed by a doctor children under 12 years of age: do not use
Warnings
Warnings Do not use in children under 12 years of age with any other product containing doxylamine unless you have time for a full night’s sleep 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 any other sleep-aid tranquilizers any other antihistamines any other drugs When using this product avoid alcoholic beverages do not drive a motor vehicle or operate machinery take only at bedtime Stop use and ask a doctor if sleeplessness persists continuously for more than two 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. In case of overdose, get medical help or contact a Poison Control Center right away.
Frequently Asked Questions
What is Sleep Aid used for?
Diphenhydramine hydrochloride is an over-the-counter antihistamine commonly used to help people fall asleep and stay asleep. This medication works by causing drowsiness and is available as a 25 mg coated tablet taken by mouth.
Is Sleep Aid a controlled substance?
Sleep Aid is not classified as a controlled substance by the DEA.
What is the generic name for Sleep Aid?
The generic name for Sleep Aid is diphenhydramine hydrochloride. There are 11 other brand versions of diphenhydramine hydrochloride.
What is the NDC code for Sleep Aid 25 mg/1?
The NDC (National Drug Code) for Sleep Aid 25 mg/1 is 76168-015, listed by Velocity Pharma LLC.
Other Diphenhydramine Brands
See all →- TopCare health NIGHTTIME MAXIMUM STRENGTH Sleep Aid50 mg/176162-438
- Allergy25 mg/176168-121
- NIGHTTIME SLEEP AID25 mg/179903-083
- Allergy Relief25 mg/183059-0021
- Banophen2 g/100g0904-5354
- Diphenhydramine Hydrochloride25 mg/10904-7237
- Nighttime Sleep Aid50 mg/30mL11673-285
- Anti-itch20 mg/g11673-895
- Topcare childrens allergy12.5 mg/5mL36800-379
- Allergy Relief25 mg/137808-590
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)