Label: MUCINEX DM- guaifenesin and dextromethorphan hydrobromide tablet, extended release
Contains inactivated NDC Code(s)
NDC Code(s): 54868-6106-0
- Packager: Physicians Total Care, Inc.
- This is a repackaged label.
- Source NDC Code(s): 63824-072
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Updated December 23, 2009
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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
- PRINCIPAL DISPLAY PANEL - 1200 mg Carton
INGREDIENTS AND APPEARANCE
guaifenesin and dextromethorphan hydrobromide tablet, extended release
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54868-6106(NDC:63824-072) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 1200 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 60 mg Inactive Ingredients Ingredient Name Strength CARBOMER 934 (UNII: Z135WT9208) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) HYPROMELLOSE (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) Product Characteristics Color white (yellow and white) Score no score Shape OVAL Size 22mm Flavor Imprint Code Mucinex;1200 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54868-6106-0 2 in 1 CARTON 1 7 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021620 04/19/2010 Labeler - Physicians Total Care, Inc. (194123980) Establishment Name Address ID/FEI Business Operations Physicians Total Care, Inc. 194123980 relabel