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

  • Label RSS
  • NDC Code(s): 0067-0003-08, 0067-0003-30
  • Packager: Novartis Consumer Health, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 02/13

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

  • Active ingredient

    Sennosides, USP, 15 mg

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  • Purpose

    Stimulant laxative

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  • Uses

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

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    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.

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  • Directions

    • swallow pill(s) with a glass of water
    • swallow pill(s) whole, do not crush, break or chew

    adults and children 12 years of age and older

    2 pills once or twice daily

    children 6 to under 12 years of age

    1 pill once or twice daily

    children under 6 years of age

    ask a doctor

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  • Other information

    • each pill contains: calcium 50 mg
    • sodium free
    • store at controlled room temperature 20-25C (68-77F). Protect from moisture.
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  • Inactive ingredients

    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

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  • Questions ?

    call 1-800-452-0051

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  • 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 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.

    Distributed by: Novartis Consumer Health, Inc. Parsippany, NJ 07054-0622 ©20xx

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  • Package/Label 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

    Ex-Lax RS Pills PDP
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  • INGREDIENTS AND APPEARANCE
    EX-LAX  REGULAR STRENGTH STIMULANT LAXATIVE
    sennosides pill
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0067-0003
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SENNOSIDES (SENNOSIDES) SENNOSIDES 15 mg
    Inactive Ingredients
    Ingredient Name Strength
    ACACIA  
    ALGINIC ACID  
    CARNAUBA WAX  
    SILICON DIOXIDE  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS  
    FERROSOFERRIC OXIDE  
    FERRIC OXIDE RED  
    FERRIC OXIDE YELLOW  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    POTASSIUM HYDROXIDE  
    PROPYLENE GLYCOL  
    SHELLAC  
    SODIUM BENZOATE  
    SODIUM LAURYL SULFATE  
    STEARIC ACID  
    SUCROSE  
    TALC  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color WHITE (Beige) Score no score
    Shape ROUND Size 11mm
    Flavor Imprint Code ex;lax;1
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0067-0003-08 1 in 1 CARTON
    1 8 in 1 BLISTER PACK
    2 NDC:0067-0003-30 2 in 1 CARTON
    2 15 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part334 01/01/2012
    Labeler - Novartis Consumer Health, Inc. (879821635)
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