GUAIFENESIN AND DEXTROMETHORPHAN HBR TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS LLC]

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GUAIFENESIN AND DEXTROMETHORPHAN HBR TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS LLC]
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NDC 65162-038-03, 65162-038-06, 65162-038-17
Set ID 5760a828-1c28-4272-a7b7-ac98466aa294
Category HUMAN OTC DRUG LABEL
Packager Amneal Pharmaceuticals LLC
Generic Name
Product Class
Product Number
Application Number ANDA209692
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  • Active ingredient(s)(in each extended-release tablet)

    Active ingredient (in each extended-release tablet)
    Dextromethorphan HBr 30 mg

    Guaifenesin 600 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 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
  • 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 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)

    When using this product

    • do not use more than directed

    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.

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

  • Directions

    600 mg/30 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 or 2 tablets every 12 hours; not more than 4 tablets in 24 hours.
    • children under 12 years of age: do not use
  • 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 broken or missing
    • store between 20° to 25°C (68° to 77°F)
  • 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 information.
    See end panel for expiration date.

     †Mucinex® is a registered trademark of Reckitt Benckiser LLC.

    Distributed by:
    Amneal Pharmaceuticals LLC
    Bridgewater, NJ 08807

    Rev. 02-2018-00

  • Principal Display Panel

    600 mg- Blister Pack

    600 mg- 30ct Label

    600 mg- 30ct Carton

    600 mg- 60ct Label

    600 mg- 60ct Carton

    600 mg Blister Carton
  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN AND DEXTROMETHORPHAN HBR 
    guaifenesin and dextromethorphan hbr tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65162-038
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN600 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg
    Inactive Ingredients
    Ingredient NameStrength
    POVIDONE (UNII: FZ989GH94E)  
    CARBOMER HOMOPOLYMER TYPE A (UNII: F68VH75CJC)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorYELLOW (light yellow) Scoreno score
    ShapeOVALSize16mm
    FlavorImprint Code AN038
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65162-038-172 in 1 CARTON11/01/2018
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:65162-038-031 in 1 CARTON11/01/2018
    230 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:65162-038-061 in 1 CARTON11/01/2018
    360 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20969211/01/2018
    Labeler - Amneal Pharmaceuticals LLC (123797875)
    Establishment
    NameAddressID/FEIBusiness Operations
    Amneal Pharmaceuticals of New York, LLC123797875ANALYSIS(65162-038) , LABEL(65162-038) , MANUFACTURE(65162-038) , PACK(65162-038)
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