EXCAUGH (GUAIFENESIN) TABLET [FORTUNE PHARMACAL COMPANY, LIMITED]

EXCAUGH (GUAIFENESIN) TABLET [FORTUNE PHARMACAL COMPANY, LIMITED]
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NDC 51467-009-01, 51467-009-02
Set ID 60803d28-ea6e-4ab9-9cc9-4909b4681ecd
Category HUMAN OTC DRUG LABEL
Packager FORTUNE PHARMACAL COMPANY, LIMITED
Generic Name
Product Class
Product Number
Application Number PART341
  • ACTIVE INGREDIENT

    Active ingredients (in each tablet)
    Guaifenesin 100 mg

  • PURPOSE

    Purpose
    Expectorant

  • INDICATIONS & USAGE

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

  • WARNINGS

    Warnings

  • ASK DOCTOR

    Ask a doctor before use if the user has
    a persistent or chronic cough such as occurs with:
       smoking
       asthma
       chronic bronchitis
       emphysema
    a cough that is accompanied by excessive phlegm (mucus)
    a high fever

  • STOP USE

    Stop use and ask a doctor if
    any of the following occurs (these could be signs of a serious condition):
       cough persists for more than 1 week
       cough tends to recur
       cough is accompanied by a fever, rash, or persistent headache

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions
    adults and children 12 years of age and over: take 2 to 4 tablets every 4 hours, not to exceed 24 tablets (2,400 mg) in 24 hours
    children 6 to under 12 years of age: take 1 to 2 tablets every 4 hours, not to exceed 12 tablets (1,200 mg) in 24 hours
    children under 6 years of age: consult a doctor

  • STORAGE AND HANDLING

    Other information
    
Phenylketonurics: Contains Phenylalanine 3.929 mg Per Tablet
    keep tightly sealed
    
store between 20 to 25º C (68 to 77º F)

  • INACTIVE INGREDIENT

    Inactive ingredients aspartame, colloidal silicon dioxide, corn starch, D&C yellow no.10 aluminum lake, lactose monohydrate, magnesium stearate, povidone K30, sodium starch glycolate.

  • QUESTIONS

    Questions or comments?(888) 221-3496 M-F 9 am to 5 pm
    you may also report serious side effects to this phone number

  • PRINCIPAL DISPLAY PANEL

    EXCAUGH
    Guaifenesin - Expectorant
    NDC 51467-009-02
    36 Tablets
    IMAGE OF CARTON

  • INGREDIENTS AND APPEARANCE
    EXCAUGH 
    guaifenesin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51467-009
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg
    Inactive Ingredients
    Ingredient NameStrength
    ASPARTAME (UNII: Z0H242BBR1)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code FORTUNE
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51467-009-012 in 1 BOX04/26/2016
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:51467-009-023 in 1 BOX03/21/2018
    212 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34104/26/2016
    Labeler - FORTUNE PHARMACAL COMPANY, LIMITED (686280561)
    Establishment
    NameAddressID/FEIBusiness Operations
    FORTUNE PHARMACAL COMPANY, LIMITED686280561manufacture(51467-009)

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