Label: TOPCARE TUSSIN COUGH LONG ACTING- dextromethorphan hydrobromide solution
- NDC Code(s): 36800-300-26
- Packager: Topco Associates LLC
- 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 March 29, 2018
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- Official Label (Printer Friendly)
- Active ingredient (in each 10 mL)
- Purpose
- Uses
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Warnings
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
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- cough that occurs with too much phlegm (mucus)
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- cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
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Directions
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- do not take more than 4 doses in any 24-hour period
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- measure only with dosing cup provided
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- keep dosing cup with product
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- mL = milliliter
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- this adult product is not intended for use in children under 12 years of age
age
dose
adults and children
12 years and over
10 mL
every 6 to 8 hours
children under 12 years
do not use
- Other information
- Inactive ingredients
- Questions or comments?
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
TOPCARE TUSSIN COUGH LONG ACTING
dextromethorphan hydrobromide solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-300 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 10 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM BENZOATE (UNII: OJ245FE5EU) MENTHOL (UNII: L7T10EIP3A) Product Characteristics Color RED Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-300-26 1 in 1 CARTON 10/21/1992 1 118 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 10/21/1992 Labeler - Topco Associates LLC (006935977)