Label: GUAIFENESIN AND DEXTROMETHORPHAN syrup
- NDC Code(s): 0904-7513-66, 0904-7513-72
- Packager: Major Pharmaceuticals
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 29, 2025
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- Official Label (Printer Friendly)
- DRUG FACTS
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Actve ingredient (in each 10 mL) Purpose
Guaifenesin 200mg ...................................................................................................................................... Expectorant
Dextromethorphan hydrobromide 20mg .......................................................................................................Cough Suppressant - 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
• cough that occurs with too much phlegm (mucus)
• cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema -
Directions
Follow dosage below or use as directed by a physician.
do not take more than 6 doses in any 24-hour period.
single use cup. Dose only with cup provided.
each cup delivers 10 mL
mL = MilliliterAge (yr) Dose (mL) adults and children
12 years and over10 mL every 4 hours
children 6 years to under 12 years 5 mL every 4 hours children under 6 years of age ask a doctor - Other information
- Inactive ingredients:
- Questions or comments?
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How Supplied
- Guaifenesin and Dextromethorphan Syrup is a red, cherry flavored syrup and is available in the following dosage form:
NDC 0904-7513-66: 10 mL unit dose cup, in a tray of ten cups
Professional Note: Guaifenesin has been shown to produce a color interference with certain clinical laboratory determinations of 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).
R10/24
Distributed by:
MAJOR® PHARMACEUTICALS
Indianapolis, IN 46268 - Guaifenesin and Dextromethorphan Syrup is a red, cherry flavored syrup and is available in the following dosage form:
- PRINCIPAL DISPLAY PANEL -10 mL Unit Dose Cup
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INGREDIENTS AND APPEARANCE
GUAIFENESIN AND DEXTROMETHORPHAN
guaifenesin and dextromethorphan syrupProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-7513 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg in 10 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg in 10 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) MENTHOL (UNII: L7T10EIP3A) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SUCROSE (UNII: C151H8M554) SODIUM CITRATE (UNII: 1Q73Q2JULR) SACCHARIN SODIUM (UNII: SB8ZUX40TY) Product Characteristics Color red Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0904-7513-72 10 in 1 CASE 02/10/2025 1 10 in 1 TRAY 1 NDC:0904-7513-66 10 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 02/10/2025 Labeler - Major Pharmaceuticals (191427277)
