GUAIFENESIN TABLET [APACE PACKAGING, LLC]

GUAIFENESIN TABLET [APACE PACKAGING, LLC]
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NDC 15338-769-05, 15338-769-11
Set ID 7b197f8e-6e13-7226-e053-2a91aa0ad2a9
Category HUMAN OTC DRUG LABEL
Packager Apace Packaging, LLC
Generic Name
Product Class
Product Number
Application Number PART341
  • Drug Facts

  • Active Ingredient

    (in each immediate-release tablet)

    Guaifenesin USP, 200 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

    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 is accompanied by fever, rash or persistent headache. This 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.

  • Directions

    • do not take more than 6 doses in any 24-hour period
    • this product is not intended for use in children under 12 years of age
      adults and children 12 years and over1 to 2 tablets every 4 hours
      Children under 12 yearsDo not use
  • Other Information

    • store at 15-30 °C (59-86 °F)
    • you may report serious side effects to: AvKARE, Inc. at 1 (855) 361-3993 
  • Inactive Ingredients

    Colloidal silicon dioxide, FD&C red #40(Al-lake), magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, stearic acid

  • Manufactured for: AvKARE, Inc., Pulaski, TN 38478 Mfg. Rev. 04/15                 AV 09/16 (P)

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 50268-382-15
    Guaifenesin Tablets USP
    200mg
    EXPECTORANT
    For Ages 12 and Over
    50 Tablets (5 x 10) Unit Dose
    5026838215

    NDC 50268-382-15
    Guaifenesin Tablets USP
    200mg
    EXPECTORANT
    For Ages 12 and Over
    50 Tablets (5 x 10) Unit Dose
    5026838215

    Drug Facts

    Active ingredient                                       Purpose
    (in each immediate-release tablet)

    Guaifenesin USP, 200 mg ...................... Expectorant

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

    Drug Facts (continued)

    Warnings
    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 last more than 7 days, comes back, or is accompanied by 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.

    Directions
    • do not take more than 6 doses in any 24-hour period
    • this product is not intended for use in children under 12 years of age

    adults and children 12 years and over                1 to 2 tablets every 4 hours

    children under 12 years                                      do not use

    Drug Facts (continued)

    Other information
    • store at 15° to 30°C (59° to 86°F).
    You may report serious side effects to: AvKARE, Inc. at 1 (855) 361-3993

    Inactive ingredients
    colloidal silicon dioxide, FD&C red #40 (Al-lake), magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, stearic acid.

    Manufactured for: AvKARE, Inc., Pulaski, TN 38478

    Mfg. Rev. 04/15 AV 09/16 (P)

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  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN 
    guaifenesin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15338-769(NDC:0603-4890)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorredScorescore with uneven pieces
    ShapeROUNDSize10mm
    FlavorImprint Code AP;151
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:15338-769-0550 in 1 BOX, UNIT-DOSE10/04/2016
    1NDC:15338-769-111 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/04/2016
    Labeler - Apace Packaging, LLC (361961142)
    Establishment
    NameAddressID/FEIBusiness Operations
    Advance Pharmaceutical Inc078301063manufacture(15338-769)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apace Packaging, LLC361961142repack(15338-769) , label(15338-769)

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