Label: GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE syrup
- NDC Code(s): 58657-505-08
- Packager: Method Pharmaceuticals
- Category: HUMAN OTC DRUG LABEL
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Updated February 11, 2020
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- Active ingredients
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
- Stop use and ask a doctor if
- If pregnant or breast-feeding,
- Keep out of reach of children.
- Inactive ingredients
- Other information
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INGREDIENTS AND APPEARANCE
GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE
guaifenesin and dextromethorphan hydrobromide syrup
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58657-505 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg in 5 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 100 mg in 5 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) MALTITOL (UNII: D65DG142WK) SACCHARIN SODIUM (UNII: SB8ZUX40TY) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) SORBITOL (UNII: 506T60A25R) Product Characteristics Color Score Shape Size Flavor GRAPE (Grape Flavor) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58657-505-08 237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/14/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 06/14/2016 Labeler - Method Pharmaceuticals (060216698)