Label: MUCINEX FAST-MAX SEVERE CONGESTION AND COUGH- dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride tablet, coated
- NDC Code(s): 63824-193-20, 63824-193-21, 63824-193-30
- 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 August 24, 2023
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- 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
- nasal congestion due to a cold
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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
- heart disease
- diabetes
- high blood pressure
- thyroid disease
- trouble urinating due to an enlarged prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough that occurs with too much phlegm (mucus)
- Directions
- Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
- Principal Display Panel - 20 Caplet Blister Pack Carton
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INGREDIENTS AND APPEARANCE
MUCINEX FAST-MAX SEVERE CONGESTION AND COUGH
dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63824-193 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 GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) ALUMINUM OXIDE (UNII: LMI26O6933) FD&C RED NO. 40 (UNII: WZB9127XOA) MICA (UNII: V8A1AW0880) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) POVIDONE K30 (UNII: U725QWY32X) SODIUM BICARBONATE (UNII: 8MDF5V39QO) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color red Score no score Shape OVAL Size 20mm Flavor Imprint Code VVV;SCC Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63824-193-20 2 in 1 CARTON 03/15/2013 05/27/2024 1 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:63824-193-30 3 in 1 CARTON 03/15/2013 09/01/2025 2 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:63824-193-21 2 in 1 CARTON 10/01/2020 3 10 in 1 BLISTER PACK; 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 03/15/2013 Labeler - RB Health (US) LLC (081049410)
