Label: LAXATIVE MAXIMUM STRENGTH- sennosides tablet, sugar coated

  • NDC Code(s): 21130-348-08
  • Packager: Better Living Brands, 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 May 3, 2023

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  • Active ingredient (in each tablet)

    Sennosides USP, 25 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 (1-800-222-1222) 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 and over2 tablets once or twice daily
    children 6 to under 12 years1 tablet once or twice daily
    children under 6 yearsask a doctor
  • Other information

    • each tablet contains: calcium 40 mg, magnesium 5 mg
    • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • see end flap for expiration date and lot number
  • Inactive ingredients

    acacia, calcium carbonate, carnauba wax, corn starch, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, iron oxide black, magnesium stearate, methylparaben, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, propylene glycol, propylparaben, shellac glaze, silicon dioxide, sodium benzoate, sodium lauryl sulfate, sucrose, talc, titanium dioxide

  • Questions or comments?

     1-800-426-9391

  • Principal Display Panel

    Signature™
    care
    Quality Guaranteed 

    COMPARE TO ex•lax® Maximum Strength
    active ingredient*

    NDC 21130-348-08

    Maximum Strength
    Laxative
    SENNOSIDES USP, 25 mg
    Stimulant laxative

    • Gentle, dependable
    • Constipation relief

    Actual Size

    24 TABLETS

    TAMPER EVIDENT: DO NOT
    USE IF PACKAGE IS
    OPENED OR IF BLISTER
    UNIT IS TORN, BROKEN
    OR SHOWS ANY SIGNS
    OF TAMPERING

    *This product is not manufactured or distributed by GSK Consumer Healthcare S.A., distributors of ex•lax® Maximum Strength.
    50844       REV0419C34808

    DISTRIBUTED BY BETTER LIVING BRANDS LLC
    P.O. BOX 99, PLEASANTON, CA 94566-0009
    1-888-723-3929
    www.betterlivingbrandsLLC.com

    OUR PROMISE
    QUALITY & SATISFACTION
    100%
    GUARANTEED
    OR YOUR MONEY BACK.

    Signature Care 44-348

    Signature Care 44-348

  • INGREDIENTS AND APPEARANCE
    LAXATIVE  MAXIMUM STRENGTH
    sennosides tablet, sugar coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-348
    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)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    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
    ColorblueScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code 44;348
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21130-348-082 in 1 CARTON01/02/200308/04/2024
    112 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 finalpart33401/02/200308/04/2024
    Labeler - Better Living Brands, LLC (009137209)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(21130-348)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837pack(21130-348)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(21130-348)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088pack(21130-348)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(21130-348)
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