Label: LEADER MAXIMUM STRENGTH LAXATIVE- calcium 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 March 15, 2012

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  • Active ingredients (in each tablet)

     Calcium sennosides 25 mg

  • Purpose

     Stimulant laxative

  • Use(s)

    •  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 a prescription 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 immediately.

  • Directions

    • Swallow pill(s) with a glass of water
    • Swallow pill(s) whole, do not crush, break or chew.
    adults and children 12 years and overtake 2 tablets once or twice daily with a glass of water
    children 6 to under 12 yearstake 1 tablet once or twice daily with a glass of water
    children under 6 yearsask a doctor 
  • Other information

    • do not use if individual blister compartments are torn or open
    • store at room temperature
    • Calcium content: 40 mg per tablet
    • Magnesium content: 10mg per tablet 
  • Inactive ingredients

    acacia, anhydrous lactose, 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, tartaric acid, titanium dioxide.

  • Principal Display Panel

    LEADER®

    Compare to the EX-LAX® Maximum Strength Tablets active ingredient*

    Maximum Strength

    Laxative

    Laxative Stimulant

    calcium sennosides, 25mg

    Gentle, dependable overnight relief of constipation

    24 TABLETS

    Distributed By: Cardinal Health

    Dublin, Ohio 43017

    www.myleader.com

    CIN 2740934

    Leader Maximum Strength Laxative

  • INGREDIENTS AND APPEARANCE
    LEADER MAXIMUM STRENGTH LAXATIVE 
    calcium sennosides tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-294
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SENNOSIDES A AND B (UNII: 1B5FPI42EN) (SENNOSIDES A AND B - UNII:1B5FPI42EN) SENNOSIDES A AND B25 mg
    Inactive Ingredients
    Ingredient NameStrength
    ACACIA (UNII: 5C5403N26O)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    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)  
    FERROUS OXIDE (UNII: G7036X8B5H)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    KAOLIN (UNII: 24H4NWX5CO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
    POVIDONE (UNII: FZ989GH94E)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorBLUEScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code 44;348
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37205-294-622 in 1 CARTON
    112 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33403/01/2012
    Labeler - Cardinal Health (097537435)
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