Label: LAXATIVE PILLS MAXIMUM STRENGTH- sennosides tablet

  • 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 November 12, 2012

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  • Active ingredient (in each tablet)

    Sennosides USP, 25 mg

  • Purpose

    Stimulant laxative

  • Uses

    •  relief of occasional constipation (irregularity). This product generally produces bowel movement within 6 to 12 hours.
  • Warnings

    Do not use

    • when abdominal pain, nausea, or vomiting are present
    • for longer than 1 week, unless directed by a doctor

    Ask a doctor before use if

    •  you notice a sudden change in bowel habits that persists over a period of 2 weeks

    Stop use and ask a doctor if

    •  you have rectal bleeding
    •  you fail to have a bowel movement after use. These may be signs of a serious condition.

    If pregnant or breast-feeding,

     ask a health care 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 take 2 tablets once or twice daily with a glass of water
      children 6 to under 12 years of age  take 1 tablet once or twice daily with a glass of water
      children under 6 years of ageconsult a doctor
  • Other information

    • each tablet contains: calcium 40 mg/ tablet
    • each tablet contains: magnesium 10 mg/ tablet
    • each tablet contains: sodium 3 mg/ tablet VERY LOW SODIUM 
    • store at 15º - 30º C (59º-86º F)
    • keep in a dry place
    • do not expose to excessive heat
    • *This product is not manufactured or distributed by Novartis Consumer Health Inc., owner of the registered trademark Ex-Lax®
  • Inactive ingredients

    acacia, calcium sulfate anhydrous, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C Blue #1 Aluminum Lake, iron oxide, iron oxide Black, iron oxide Yellow, kaolin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, shellac, sodium lauryl sulfate, stearic acid, sugar, talc, and titanium dioxide. May also contain:  anhydrous lactose, isopropyl alcohol, Lake Brilliant Blue FCF, malto dextrin, Opacode Black S-1-17823, Opagloss 6000P, tartaric acid

  • Questions or Comments?

    Call toll free 1-877-753-3935

  • Principal Display Panel

    *Compare to maximum strength EX-LAX® active ingredient

    Maximum Strength

    Laxative Pills

    Sennosides USP, 25 mg

    stimulant laxative

    natural senna ingredient

    for gentle, dependable overnight relief

    TAMPER EVIDENT- USE ONLY IF BLISTERS ARE INTACT

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

  • Product Label

    Good Neighbour Pharmacy

    Senosides 25 mg

  • INGREDIENTS AND APPEARANCE
    LAXATIVE PILLS  MAXIMUM STRENGTH
    sennosides tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24385-369
    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 SULFATE ANHYDROUS (UNII: E934B3V59H)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    KAOLIN (UNII: 24H4NWX5CO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POVIDONES (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    TARTARIC ACID (UNII: W4888I119H)  
    Product Characteristics
    ColorBLUEScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code TCL083;S25
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24385-369-622 in 1 CARTON
    112 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart33407/08/2010
    Labeler - Amerisourcebergen Drug Corporation (Good Neighbour Pharmacy) (007914906)
    Registrant - P and L Development of New York Corporation (800014821)
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