Label: GUAIFENESIN AND DEXTROMETHORPHAN HBR tablet, extended release

  • NDC Code(s): 65162-039-03, 65162-039-06, 65162-039-17
  • Packager: Amneal Pharmaceuticals LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 25, 2024

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  • Active ingredient(s)(in each extended-release tablet)
    Active ingredient (in each extended-release tablet) Dextromethorphan HBr 60 mg - Guaifenesin 1200 mg
  • Purpose
    Guaifenesin - Expectorant - Dextromethorphan HBr - Cough suppressant
  • 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 ...
  • Warnings
    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 ...
  • Directions
    1200 mg/60 mg - do not crush, chew, or break tablet - take with a full glass of water - this product can be administered without regard for timing of meals - adults and children 12 years and older: 1 ...
  • Other information
    Bottle: Tamper evident: Do not use if carton is open or if printed foil under cap is broken or missing - Blister: Do not use if carton is open or if printed seal with product name on blister is ...
  • Inactive ingredients
    carbomer, colloidal silicon dioxide, D&C yellow #10 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and talc
  • Questions?
    1-877-835-5472 - You may also report side effects to this phone number. Parents: Learn about teen medicine abuse - www.StopMedicineAbuse.org - Keep the carton. It contains important ...
  • Principal Display Panel
    1200mg Blister Pack ...
  • INGREDIENTS AND APPEARANCE
    Product Information