Label: NIGHTTIME SLEEP AID- doxylamine succinate tablet
- NDC Code(s): 59779-441-64
- Packager: CVS Pharmacy
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated June 3, 2009
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- Active ingredient (in each tablet)
Doxylamine succinate 25 mgClose
- 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
- trouble urinating due to an enlarged prostate gland
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.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
- 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
- Other information
- store at 68°-77°F (20°-25°C)
- retain in carton until time of use
- see carton end panel for lot number and expiration date
- Inactive ingredients
dibasic calcium phosphate, FD&C blue no. 1 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium starch glycolateClose
- Questions or comments?
- Principal Display Panel
Compare to the active ingredient in Unisom® SleepTabs®
Doxylamine Succinate Tablets, 25 mg USP
Nighttime Sleep Aid
Fall Asleep Fast
Safe. Proven Effective
Just One Tablet Per Dose
Nighttime Sleep Aid Tablets Carton
- INGREDIENTS AND APPEARANCE
NIGHTTIME SLEEP AID
doxylamine succinate tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-441 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 25 mg Product Characteristics Color BLUE Score no score Shape OVAL Size 10mm Flavor Imprint Code L441 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59779-441-64 2 in 1 CARTON 1 16 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040167 07/23/1997 Labeler - CVS Pharmacy (062312574)