Label: DEXTROMETHORPHAN HBR. AND GUAIFENESIN solution
- NDC Code(s): 57237-312-05, 57237-312-51, 57237-313-01, 57237-313-18
- Packager: Rising Pharma Holdings, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 11, 2024
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- Official Label (Printer Friendly)
- DRUG FACTS
- 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
• cough that occurs with too much phlegm (mucus)
• cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema -
DOSAGE & ADMINISTRATION
Directions
• do not take more than 6 doses in any 24 hour period
20 mg-200 mg/10 mL
age dose Children under 12 years of age Do not use
Adults and children over 12 years of age 10 mL (1 unit dose) every 4 hours
10 mg-100 mg/5 mL
age dose Children under 6 years of age Do not use Children 6 to under 12 years of age 5 mL (1 unit dose) every 4 hours Adults and children over 12 years of age 10 mL (2 unit dose) every 4 hours - OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
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HOW SUPPLIED
NDC Information -
Each 5 mL of Guaifenesin Syrup and Dextromethorphan contains Guaifenesin 100mg and Dextromethorphan Hydrobromide 10mg and is supplied in the following oral dosage forms:
NDC 57237-312-05 unit dose cup 5mL
NDC 57237-312-51 (100 x 5 mL) unit-dose cups
Each 10 mL of Guaifenesin Syrup and Dextromethorphan contains Guaifenesin 200mg and Dextromethorphan Hydrobromide 20mg and is supplied in the following oral dosage forms:NDC 57237-313-01 unit dose cup 10mL
NDC 57237-313-18 (80 x 10 mL) unit-dose cups - QUESTIONS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DEXTROMETHORPHAN HBR. AND GUAIFENESIN
dextromethorphan hbr. and guaifenesin solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57237-312 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 ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C RED NO. 4 (UNII: X3W0AM1JLX) MENTHOL (UNII: L7T10EIP3A) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SODIUM CITRATE (UNII: 1Q73Q2JULR) SUCRALOSE (UNII: 96K6UQ3ZD4) 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:57237-312-51 100 in 1 BOX, UNIT-DOSE 06/12/2023 1 NDC:57237-312-05 5 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 M012.85 06/12/2023 DEXTROMETHORPHAN HBR. AND GUAIFENESIN
dextromethorphan hbr. and guaifenesin solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57237-313 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. 4 (UNII: X3W0AM1JLX) MENTHOL (UNII: L7T10EIP3A) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SODIUM CITRATE (UNII: 1Q73Q2JULR) SUCRALOSE (UNII: 96K6UQ3ZD4) 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:57237-313-18 80 in 1 BOX, UNIT-DOSE 06/12/2023 1 NDC:57237-313-01 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 M012.85 06/12/2023 Labeler - Rising Pharma Holdings, Inc. (116880195)
