Label: GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE tablet, extended release
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Contains inactivated NDC Code(s)
NDC Code(s): 63868-391-14 - Packager: CHAIN DRUG MARKETING ASSOCIATION INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated October 16, 2017
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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Uses
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- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
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- temporarily relieves:
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- cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
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- the intensity of coughing
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- the impulse to cough to help you get to sleep
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Warnings
Do not use
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- for children under 12 years of age
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- 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
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- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
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- cough accompanied by too much phlegm (mucus)
- Directions
- Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - 1200 mg/60 mg Tablet Blister Pack Carton
NDC 63868-391-14
QC®
QUALITY
CHOICE-
†Compare to
Active Ingredients in
Maximum Strength
Mucinex® DM
Maximum Strength
Mucus Relief DM
Guaifenesin 1200 mg
& Dextromethorphan HBr 60 mg
Extended-Release TabletsExpectorant & Cough Suppressant
12 Hour
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- Controls Cough
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- Thins and Loosens Mucus
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- Immediate and Extended Release
14 Extended-Release Tablets
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INGREDIENTS AND APPEARANCE
GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE
guaifenesin and dextromethorphan hydrobromide tablet, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-391 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 HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED) (UNII: K6MOM3T5YL) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) Product Characteristics Color 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:63868-391-14 2 in 1 CARTON 12/10/2017 1 14 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 12/10/2017 Labeler - CHAIN DRUG MARKETING ASSOCIATION INC (011920774) Establishment Name Address ID/FEI Business Operations RECKITT BENCKISER HEALTHCARE INTERNATIONAL LTD 230780363 MANUFACTURE(63868-391)