Label: EQUATE SLEEP AID- doxylamine succinate tablet
- NDC Code(s): 49035-441-64
- Packager: Wal-Mart Stores Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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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
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- INGREDIENTS AND APPEARANCE
EQUATE SLEEP AID
doxylamine succinate tablet
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:49035-441 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DOXYLAMINE SUCCINATE (DOXYLAMINE) 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:49035-441-64 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 02/25/1997 Labeler - Wal-Mart Stores Inc (051957769)