Label: EXCAUGH- guaifenesin tablet

  • NDC Code(s): 51467-009-01, 51467-009-02
  • Packager: FORTUNE PHARMACAL COMPANY, LIMITED
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated October 15, 2018

If you are a consumer or patient please visit this version.

  • 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)