Label: GUAIFENESIN tablet, extended release

  • NDC Code(s): 65162-036-02, 65162-036-03, 65162-036-06, 65162-037-03, view more
    65162-037-06, 65162-037-28
  • Packager: Amneal Pharmaceuticals LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 7, 2024

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  • Active ingredient(s)

    Active ingredient (in each extended-release tablet)

    Guaifenesin 600 mg

    Active ingredient (in each extended-release tablet)

    Guaifenesin 1200 mg

  • Purpose

    Expectorant

  • Uses

    helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

  • Warnings

    Do not use

    • for children under 12 years of age

    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.

    Pregnancy/Breastfeeding

    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

    • do not crush, chew, or break extended-release tablet
    • take with a full glass of water
    • this product can be administered without regard for the timing of meals
    • adults and children 12 years of age and over: 1 or 2 extended-release tablets every 12 hours. Do not exceed 4 extended-release tablets in 24 hours.
    • children under 12 years of age: do not use

     1200 mg

    • do not crush, chew, or break extended-release tablet
    • take with a full glass of water
    • this product can be administered without regard for the timing of meals
    • adults and children 12 years of age and over: 1 extended-release tablet every 12 hours; not more than 2 extended-release tablets in 24 hours.
    • children under 12 years of age: do not use
  • Other information

    • Tamper evident: Do not use if printed foil under cap is broken or missing.
  • Storage

    • store between 20° to 25°C (68° to 77°F)
  • Inactive ingredients

    carbomer, colloidal silicon dioxide, FD&C blue #1 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.

    Distributed by:
    Amneal Pharmaceuticals LLC
    Bridgewater, NJ  08807

    Rev. 10-2024-01

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    600 mg Blister

    600 mg Blister Carton

    600 mg Label

    600 mg Carton

    1200 mg Blister

    1200 mg Blister Carton

    1200 mg Label

    1200 mg Carton
  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN 
    guaifenesin tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65162-036
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN600 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    Colorblue (light blue) Scoreno score
    ShapeOVALSize16mm
    FlavorImprint Code AN036
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65162-036-022 in 1 CARTON07/27/2018
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:65162-036-031 in 1 CARTON07/27/2018
    230 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:65162-036-061 in 1 CARTON07/27/2018
    360 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20734207/27/2018
    GUAIFENESIN 
    guaifenesin tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65162-037
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN1200 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    Colorblue (light blue) Scoreno score
    ShapeOVALSize22mm
    FlavorImprint Code AN037
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65162-037-282 in 1 CARTON07/27/2018
    114 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:65162-037-031 in 1 CARTON07/27/2018
    230 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:65162-037-061 in 1 CARTON07/27/2018
    360 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20734207/27/2018
    Labeler - Amneal Pharmaceuticals LLC (123797875)
    Establishment
    NameAddressID/FEIBusiness Operations
    Amneal Pharmaceuticals of New York, LLC123797875analysis(65162-036, 65162-037) , label(65162-036, 65162-037) , manufacture(65162-036, 65162-037) , pack(65162-036, 65162-037)
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