Label: EX-LAX REGULAR STRENGTH STIMULANT LAXATIVE- sennosides pill
EX-LAX REGULAR STRENGTH STIMULANT LAXATIVE- sennosides tablet

  • NDC Code(s): 0067-0003-08, 0067-0003-30, 0067-8141-01, 0067-8141-02
  • Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 December 3, 2020

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

  • Active ingredient (in each tablet)

    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

    swallow tablet(s) with a glass of water
    swallow tablet(s) 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 45 mg, magnesium 5mg
    store at controlled room temperature 20-25°C (68-77°F)
  • Inactive ingredients (0067-0003)

    acacia, alginic acid, carnauba wax, colloidal silicon dioxide, dibasic calcium phosphate, iron oxides, magnesium stearate, microcrystalline cellulose, potassium hydroxide, pregelatinized starch, propylene glycol, shellac, sodium benzoate, sodium lauryl sulfate, stearic acid, sucrose, talc, titanium dioxide

  • Inactive Ingredients (0067-8141)

    acacia, calcium carbonate, carnauba wax, corn starch, dibasic calcium phosphate, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, methylparaben, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, propylene glycol, propylparaben, shellac, silicon dioxide, sodium benzoate, sodium lauryl sulfate, sucrose, talc, titanium dioxide

  • Questions ?

    call 1-855-221-5432

  • Principal Display Panel

    NDC 0067-0003-30

    Regular Strength

    ex•lax®

    SENNOSIDES, USP, 15 mg

    STIMULANT LAXATIVE

    RELIEF GUARANTEED EVERY TIME

    GENTLE OVERNIGHT RELIEF YOU CAN TRUST

    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 Novartis, attention Consumer Affairs, for full refund.

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

    Trademarks are owned by or licensed to GSK group of companies

    Distributed by: Novartis Consumer Health, Inc.

    Parsippany, NJ 07054-0622

    Ex-Lax RS Pills PDP
  • Principal Display Panel

    NDC 0067-8141-02

    ex•lax®

    SENNOSIDES, 15 mg

    REGULAR STRENGTH

    STIMULANT LAXATIVE

    RELIEF GUARANTEED

    GENTLE OVERNIGHT RELIEF YOU CAN TRUST

    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.

    Trademarks are owned by or licensed to the GSK group of companies.

    Distributed by:

    GSK Consumer Healthcare

    Warren, NJ 07059

    ©2017 GSK or its licensor. All rights reserved

    13143

    exlax regular strength tablet 30 count carton
  • INGREDIENTS AND APPEARANCE
    EX-LAX  REGULAR STRENGTH STIMULANT LAXATIVE
    sennosides pill
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-0003
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES15 mg
    Inactive Ingredients
    Ingredient NameStrength
    ACACIA (UNII: 5C5403N26O)  
    ALGINIC ACID (UNII: 8C3Z4148WZ)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITE (Beige) Scoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code ex;lax;1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0067-0003-081 in 1 CARTON01/01/201211/30/2019
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0067-0003-302 in 1 CARTON01/01/201211/30/2019
    215 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 finalpart33401/01/201211/30/2019
    EX-LAX  REGULAR STRENGTH STIMULANT LAXATIVE
    sennosides tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-8141
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES15 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)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    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
    ColorBROWN (Tan) Scoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code ex;lax;1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0067-8141-011 in 1 CARTON07/01/2017
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0067-8141-022 in 1 CARTON07/01/2017
    215 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)