Active Ingredient (In Each Tablet)
Doxylamine succinate 25 mg
Night Time Sleep Aid Tablet
FDA Label NDC 80513-371
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Advanced Rx Llc for the product Night Time Sleep Aid (NDC 80513-371). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each tablet), purpose, use, ask a doctor before use if you have, ask a doctor or pharmacist before use if, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Nighttime sleep-aid
Use
- helps to reduce difficulty in falling asleep
Ask A Doctor Before Use If You Have
- a breathing problem such as asthma, emphysema or chronic bronchitis
- difficulty in urination due to enlargement of the prostate gland
- glaucoma
Ask A Doctor Or Pharmacist Before Use If
you are taking any other drugs.
When Using This Product
- avoid alcoholic beverages
- 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. [1-800-222-1222]
Directions
- adults and children 12 years and over:take one tablet 30 minutes before going to bed; take once daily or as directed by a doctor
- children under 12 years:do not use
Other Information
- store at 20°-25°C (68° and 77° F)
- protect from excessive moisture
- DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED.
Inactive Ingredients
dicalcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium starch glycolate
Questions?
call toll-free 1-800-630-8895
Other
Distributed by:
ADVANCED RX LLC
1942 NE 163rd St North Miami Beach,
FL 33162 U.S.A
Package Label.Principal Display Panel
*Compare to the active ingredient in Unisom ®Sleeptabs ®
NDC 80513-371-25
Night Time Sleep Aid
Doxylamine Succinate 25 mg
225 Tablets
*This product is not manufactured or distributed by the owner of the registered trademark Unisom ®Sleeptabs ®.
Label (Label)
Good Neighbor 44-386
Good Neighbor 44-386
* Please review the disclaimer below.
