Label: NIGHTTIME SLEEP AID- doxylamine succinate tablet
- NDC Code(s): 59779-441-01, 59779-441-64, 59779-441-67
- Packager: CVS Pharmacy
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 24, 2022
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- Active ingredient (in each tablet)
- Purpose
- Use
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Warnings
Ask doctor before use if you have
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- a breathing problem such as asthma, emphysema or chronic bronchitis
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- glaucoma
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- trouble urinating due to an enlarged prostate gland
- Directions
- Other information
- Inactive ingredients
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INGREDIENTS AND APPEARANCE
NIGHTTIME SLEEP AID
doxylamine succinate tabletProduct 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 Inactive Ingredients Ingredient Name Strength MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J) DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Product Characteristics Color BLUE Score 2 pieces 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 07/23/1997 01/01/2016 1 16 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:59779-441-67 48 in 1 CARTON 04/18/2018 11/30/2022 2 1 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:59779-441-01 1 in 1 CARTON 05/09/2018 3 96 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040167 07/23/1997 Labeler - CVS Pharmacy (062312574)