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
- 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 August 14, 2023
If you are a consumer or patient please visit this version.
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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 final part341 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 final part341 06/12/2023 Labeler - Rising Pharma Holdings, Inc. (116880195)
