Label: SILTUSSIN DM- guaifenesin and dextromethorphan hydrobromide liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 64725-0209-1 - Packager: TYA Pharmaceuticals
- This is a repackaged label.
- Source NDC Code(s): 54838-209
- 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 June 27, 2014
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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Warnings
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. Do not use
- Ask a doctor before use if you have
- Stop use and ask a doctor if
- If pregnant or breast-feeding
- KEEP OUT OF REACH OF CHILDREN
- Directions
- INACTIVE INGREDIENT
- Other information
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SILTUSSIN DM
guaifenesin and dextromethorphan hydrobromide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64725-0209(NDC:54838-209) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin 100 mg in 5 mL Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide 10 mg in 5 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) MENTHOL (UNII: L7T10EIP3A) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM BENZOATE (UNII: OJ245FE5EU) SUCROSE (UNII: C151H8M554) WATER (UNII: 059QF0KO0R) Product Characteristics Color Score Shape Size Flavor STRAWBERRY (STRAWBERRY FLAVOR) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64725-0209-1 8 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 09/05/1992 Labeler - TYA Pharmaceuticals (938389038) Registrant - TYA Pharmaceuticals (938389038) Establishment Name Address ID/FEI Business Operations TYA Pharmaceuticals 938389038 RELABEL(64725-0209) , REPACK(64725-0209)