Sleep Aid 25 mg/1
Doxylamine succinate · TABLET · COSTCO WHOLESALE CORPORATION
Sleep Aid is a tablet containing doxylamine succinate at 25 mg/1, taken oral. Manufactured by COSTCO WHOLESALE CORPORATION.
Key Facts
- Brand Name
- Sleep Aid
- Generic Name
- Doxylamine succinate
- NDC Code (Product)
63981-986- Manufacturer
- COSTCO WHOLESALE CORPORATION
- Strength
- 25 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA040564
- Marketing Start
- 05/03/2019
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?
Sleep Aid contains Doxylamine succinate. It is a tablet taken oral. Consult your doctor for specific uses.
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 Doxylamine succinate. There are 9 other brand versions of Doxylamine succinate.
What is the NDC code for Sleep Aid 25 mg/1?
The NDC (National Drug Code) for Sleep Aid 25 mg/1 is 63981-986, listed by COSTCO WHOLESALE CORPORATION.
Other Sleep Aid Dosages
Other Doxylamine Brands
See all →- TopCare Sleep Aid25 mg/136800-441
- dg health sleep aid25 mg/155910-909
- berkley and jensen sleep aid25 mg/168391-441
- sleep aid25 mg/10363-3462
- Doxylamine succinate and Pyridoxine hydrochloride10 mg/169452-206
- Doxylamine Succinate and Pyridoxine Hydrochloride10 mg/10378-4615
- Vicks NyQuil ALLERGY6.25 mg/15mL84126-346
- sleep aid25 mg/111822-0441
- Nighttime Sleep-Aid25 mg/130142-366
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)