EX-LAX MAXIMUM STRENGTH STIMULANT LAXATIVE (SENNOSIDES) PILL [GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC]

EX-LAX MAXIMUM STRENGTH STIMULANT LAXATIVE (SENNOSIDES) PILL [GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC]
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NDC 0067-8142-01, 0067-8142-02
Set ID fb170340-c996-46cf-b165-84e136ba4151
Category HUMAN OTC DRUG LABEL
Packager GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Generic Name
Product Class
Product Number
Application Number PART334
  • Active ingredient

    Sennosides 25 mg

  • Purpose

    Stimulant laxative

  • Uses

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

    Do Not Use

    Do not use laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor

    Ask 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

    swallow tablet with a glass of water
    swallow tablet whole, do not crush, break or chew

    adults and children 12 years of age and older

    2 tablets once or twice daily

    children 6 to under 12 years of age

    1 tablet once or twice daily

    children under 6 years of age

    ask a doctor

  • Other information

    each tablet contains: calcium 40 mg, magnesium 5 mg
    store at controlled room temperature 20-25C (68-77F).
  • Inactive ingredients

    acacia, calcium carbonate, carnauba wax, corrn starch dibasic calcium phosphate, FD&C blue no.1 aluminum lake, iron oxide black, magnesium stearate, methyl paraben, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, propylene glycol, propyl paraben, shellac, silicon dioxide, sodium benzoate, sodium lauryl sulfate, sucrose, talc, titanium dioxide

  • Questions or Comments?

    call 1-855-221-5432

  • Additional information listed on other panels

    The Ex•Lax® Guarantee: When taken as directed, Ex•Lax® is guaranteed to work gently and effectively overnight or your money back. Return product to GSK, attention Consumer Affairs, for full refund.

    Tamper Evident Feature: Ex•Lax® Tablets are sealed in blister packets. Use only if the individual seal is unbroken.

    Distributed by: GlaxoSmithKline Consumer Healthcare Holdings (US), LLC. Warren, NJ 07059 ©20xx

  • Principal Display Panel

    NDC 0067-8142-01

    Maximum Strength

    ex•lax®

    SENNOSIDES, USP, 25 mg

    STIMULANT LAXATIVE

    RELIEF GUARANTEED

    GENTLE OVERNIGHT RELIEF YOU CAN TRUST

    13142 ExLax- 24 ct.jpg
  • INGREDIENTS AND APPEARANCE
    EX-LAX  MAXIMUM STRENGTH STIMULANT LAXATIVE
    sennosides pill
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-8142
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES25 mg
    Inactive Ingredients
    Ingredient NameStrength
    ACACIA (UNII: 5C5403N26O)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SHELLAC (UNII: 46N107B71O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorBLUEScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code ex;lax;1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0067-8142-012 in 1 CARTON07/01/2017
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0067-8142-024 in 1 CARTON07/01/2017
    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 not finalpart33407/01/2017
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

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