Label: MUCINEX FAST-MAX DM MAX HONEY AND BERRY FLAVOR- dextromethorphan hydrobromide and guaifenesin solution
- NDC Code(s): 63824-535-66
- Packager: RB Health (US) LLC
- 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 January 10, 2022
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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Uses
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
- temporarily relieves:
- cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
- the intensity of coughing
- the impulse to cough to help you get to sleep
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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
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough that occurs with too much phlegm (mucus)
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Directions
- do not take more than 6 doses in any 24-hour period
- measure only with dosing cup provided
- do not use dosing cup with other products
- dose as follows or as directed by a doctor
- adults and children 12 years of age and over: 20 mL in dosing cup provided every 4 hours
- children under 12 years of age: do not use
- Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 180 mL Bottle Label
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INGREDIENTS AND APPEARANCE
MUCINEX FAST-MAX DM MAX HONEY AND BERRY FLAVOR
dextromethorphan hydrobromide and guaifenesin solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63824-535 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 20 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 400 mg in 20 mL Inactive Ingredients Ingredient Name Strength ammonium glycyrrhizate (UNII: 3VRD35U26C) anhydrous citric acid (UNII: XF417D3PSL) edetate disodium (UNII: 7FLD91C86K) propylene glycol (UNII: 6DC9Q167V3) water (UNII: 059QF0KO0R) sodium benzoate (UNII: OJ245FE5EU) sorbitol (UNII: 506T60A25R) sucralose (UNII: 96K6UQ3ZD4) xanthan gum (UNII: TTV12P4NEE) Product Characteristics Color Score Shape Size Flavor HONEY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63824-535-66 180 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package 06/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 06/01/2020 Labeler - RB Health (US) LLC (081049410)
