NDC | 56062-668-38, 56062-668-40 |
Set ID | cae98e03-df0c-4eda-b0d7-22169d9ba66f |
Category | HUMAN OTC DRUG LABEL |
Packager | Publix Super Markets Inc |
Generic Name | |
Product Class | Antihistamine |
Product Number | |
Application Number | PART341 |
- Active ingredients (in each 30 mL)
- Purpose
- Uses
-
Warnings
Do not use
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- 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
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- glaucoma
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- cough that occurs with too much phlegm (mucus)
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- a breathing problem such as emphysema or chronic bronchitis
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- 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
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- may cause marked drowsiness
- •
- avoid alcoholic drinks
- •
- be careful when driving a motor vehicle or operating machinery
- •
- alcohol, sedatives, and tranquilizers may increase drowsiness
- Directions
- Other information
- Inactive ingredients
- Principal Display Panel
-
INGREDIENTS AND APPEARANCE
NITETIME COUGH
dextromethorphan hydrobromide, doxylamine succinate solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:56062-668 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 (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM CITRATE (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:56062-668-38 296 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/20/2003 11/09/2013 2 NDC:56062-668-40 355 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/27/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 01/20/2003 Labeler - Publix Super Markets Inc (006922009)