EX-LAX REGULAR STRENGTH CHOCOLATED STIMULANT LAXATIVE (SENNOSIDES) TABLET, CHEWABLE [GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC]

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  • EX-LAX REGULAR STRENGTH CHOCOLATED STIMULANT LAXATIVE (SENNOSIDES) TABLET, CHEWABLE [GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC]

EX-LAX REGULAR STRENGTH CHOCOLATED STIMULANT LAXATIVE (SENNOSIDES) TABLET, CHEWABLE [GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC]
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NDC 0067-8140-01, 0067-8140-02, 0067-8140-03
Set ID 59a26a7f-516f-4507-8dec-f40cf6cfaffc
Category HUMAN OTC DRUG LABEL
Packager GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Generic Name
Product Class
Product Number
Application Number PART334
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  • Active ingredient

    Sennosides 15 mg

  • Purpose

    Stimulant laxative

  • Uses

    •
    relieves occasional constipation (irregularity)
    •
    generally produces bowel movement in 6 to 12 hours
  • Warnings

  • Do not use

    laxative products when abdominal pain, nausea or vomiting are present unless directed by a doctor

  • Ask a doctor before use if you have

    noticed a sudden change in bowel habits that persists over a period of 2 weeks

  • Ask a doctor or pharmacist before use if you are

    taking any other drug. Laxatives may affect how other drugs work. Take this product 2 or more hours before or after other drugs.

  • When using this product

    do not use for a period longer than 1 week

  • Stop use and ask a doctor if

    rectal bleeding or failure to have a bowel movement occur after use of a laxative. These may be signs of a serious condition.

  • 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

    adults and children 12 years of age and older

    chew 2 chocolated pieces once or twice daily

    children 6 to under 12 years of age

    chew 1 chocolated piece once or twice daily

    children under 6 years of age

    ask a doctor
  • Other information

    •
    each piece contains: potassium 10 mg
    •
    store at 15-25oC (59-77oF)
  • Inactive ingredients

    cocoa powder, hydrogenated vegetable oils (palm kernel, palm), salt, soy lecithin, sugar, vanilla, whey powder (milk)

  • Questions or comments?

    call 1-855-221-5432

  • Principal Display Panel

    13030_Ex-Lax choclate 48ct carton.jpg
  • INGREDIENTS AND APPEARANCE
    EX-LAX  REGULAR STRENGTH CHOCOLATED STIMULANT LAXATIVE
    sennosides tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-8140
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES15 mg
    Inactive Ingredients
    Ingredient NameStrength
    COCOA (UNII: D9108TZ9KG)  
    HYDROGENATED PALM KERNEL OIL (UNII: FM8D1RE2VP)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    SUCROSE (UNII: C151H8M554)  
    VANILLIN (UNII: CHI530446X)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WHEY (UNII: 8617Z5FMF6)  
    Product Characteristics
    ColorBROWNScoreno score
    ShapeRECTANGLE (Bar) Size68mm
    FlavorCHOCOLATEImprint Code ex;lax
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0067-8140-011 in 1 BOX08/01/2017
    112 in 1 PACKAGE; Type 0: Not a Combination Product
    2NDC:0067-8140-022 in 1 BOX08/01/2017
    212 in 1 PACKAGE; Type 0: Not a Combination Product
    3NDC:0067-8140-034 in 1 BOX08/01/2017
    312 in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33408/01/2017
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
    Registrant - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
    Establishment
    NameAddressID/FEIBusiness Operations
    Alps Pharmaceutical Ind. Co., Ltd.717077197API MANUFACTURE(0067-8140)
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