Label: NITETIME COUGH- dextromethorphan hydrobromide, doxylamine succinate solution
- NDC Code(s): 41250-668-30, 41250-668-38, 41250-668-40
- Packager: Meijer Distribution Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated August 1, 2022
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- Official Label (Printer Friendly)
- Active ingredients (in each 30 mL)
Do not use
- if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have
- cough that occurs with too much phlegm (mucus)
- a breathing problem such as emphysema or chronic bronchitis
- persistent or chronic cough as occurs with smoking, asthma, or emphysema
- trouble urinating due to an enlarged prostate gland
When using this product
- excitability may occur, especially in children
- may cause marked drowsiness
- avoid alcoholic drinks
- be careful when driving a motor vehicle or operating machinery
- alcohol, sedatives, and tranquilizers may increase drowsiness
Stop use and ask a doctor if
cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
- Other information
- Inactive ingredients
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INGREDIENTS AND APPEARANCE
dextromethorphan hydrobromide, doxylamine succinate solution
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41250-668 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 30 mg in 30 mL DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 12.5 mg in 30 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) Product Characteristics Color RED (Dark Red) Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41250-668-30 177 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/03/2003 07/19/2013 2 NDC:41250-668-38 296 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/03/2003 11/12/2013 3 NDC:41250-668-40 355 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/24/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 03/03/2003 Labeler - Meijer Distribution Inc (006959555)