GUAIFENESIN TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS LLC]

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GUAIFENESIN TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS LLC]
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NDC 65162-036-02, 65162-036-03, 65162-036-06, 65162-037-03, 65162-037-06, 65162-037-28
Set ID ad67e6fd-a68f-44db-9718-84a2cef86e09
Category HUMAN OTC DRUG LABEL
Packager Amneal Pharmaceuticals LLC
Generic Name
Product Class
Product Number
Application Number ANDA207342
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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 tablet
    • take with a full glass of water
    • this product can be administered without regards for the timing of meals
    • adults and children 12 years of age and over: 1 or 2 tablets every 12 hours. Do not exceed 4 tablets in 24 hours.
    • children under 12 years of age: do not use

     1200 mg

    • do not crush, chew, or break tablet
    • take with a full glass of water
    • this product can be administered without regards for the timing of meals
    • adults and children 12 years of age and over: 1 tablet every 12 hours. Do not exceed 2 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. 12-2017-00

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    600mg blister

    600mg blister carton

    600mg 30ct label

    600mg 30ct carton

    600mg 60ct label

    600mg 60ct carton

    1200mg blister

    1200mg blister carton

    1200mg 30ct label

    1200mg 30ct carton

    1200mg 60ct label

    1200mg 60ct 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(65162-037, 65162-036) , LABEL(65162-037, 65162-036) , MANUFACTURE(65162-037, 65162-036) , PACK(65162-037, 65162-036)
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