Label: MUCINEX DM- guaifenesin and dextromethorphan hydrobromide tablet, extended release
- NDC Code(s): 50090-1077-0
- Packager: A-S Medication Solutions
- This is a repackaged label.
- Source NDC Code(s): 63824-056
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Updated May 19, 2022
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- 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
Do not use
- for children under 12 years of age
- 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 accompanied by too much phlegm (mucus)
Stop use and ask a doctor if
- cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.
- Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- HOW SUPPLIED
- Guaifenesin and Dextromethorphan Hydrobromide
INGREDIENTS AND APPEARANCE
guaifenesin and dextromethorphan hydrobromide tablet, extended release
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50090-1077(NDC:63824-056) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 600 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 30 mg Inactive Ingredients Ingredient Name Strength Carbomer Homopolymer Type B (Allyl Pentaerythritol Crosslinked) (UNII: HHT01ZNK31) D&C yellow no. 10 (UNII: 35SW5USQ3G) aluminum oxide (UNII: LMI26O6933) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) magnesium stearate (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) Product Characteristics Color WHITE (yellow and white) Score no score Shape OVAL Size 16mm Flavor Imprint Code Mucinex;600 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50090-1077-0 1 in 1 CARTON 11/28/2014 1 20 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 NDA NDA021620 06/26/2012 Labeler - A-S Medication Solutions (830016429) Establishment Name Address ID/FEI Business Operations A-S Medication Solutions 830016429 RELABEL(50090-1077)