Label: SUN MARK TUSSIN DM COUGH AND CHEST CONGESTION- dextromethorphan hydrobromide, guaifenesin solution
- NDC Code(s): 49348-017-34, 49348-017-37, 49348-017-39
- Packager: Strategic Sourcing Services LLC
- Category: HUMAN OTC DRUG LABEL
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 January 31, 2020
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- Official Label (Printer Friendly)
- Active ingredients (in each 10 mL)
- Purposes
- 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)
- •
- cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
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Directions
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- do not take more than 6 doses in any 24-hour period
- •
- 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 4 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
SUN MARK TUSSIN DM COUGH AND CHEST CONGESTION
dextromethorphan hydrobromide, guaifenesin solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49348-017 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg in 10 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg in 10 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color RED (Orange-Red) Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49348-017-34 1 in 1 CARTON 07/03/2003 1 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:49348-017-37 1 in 1 CARTON 06/27/2003 2 236 mL in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:49348-017-39 1 in 1 CARTON 09/19/2003 3 354 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 06/27/2003 Labeler - Strategic Sourcing Services LLC (116956644)