Label: MAXIMUM STRENGTH LAXATIVE PILLS- 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 April 16, 2019

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

  • ACTIVE INGREDIENT

    Each Tablet contains:

    CALCIUM SENNOSIDES 25 mg

  • INACTIVE INGREDIENTS

    acacia, calcium sulfate anhydrous, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue#1, iron oxide, iron oxide black, iron oxide yellow, kaolin, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, shellac, stearic acid, sugar, talc, titanium dioxide

  • PURPOSE

    stool softener, laxative

  • DOSAGE & ADMINISTRATION

    Directions:

    Take preferably at bedtime or as directed by a doctor. If you do not have a comfortable bowel movement by the second day, increase dose by one tablet (not to exceed maximum dosage) or decrease dose until you are comfortable.

    Adults and children 12 years and over - starting dosage: 2 tablets once a day maximum dosage: 4 tablets twice a day

    Children 6 to under 12 years - starting dosage: 1 tablet once a day maximum dosage: 2 tablets twice a day

    Children 6 to under 12 years - starting dosage: 1/2 tablet once a day maximum dosage: 1 tablet twice a day

    Children under 2 years - Ask a doctor

  • INDICATIONS & USAGE

    Uses:

    Relieves occasional constipation (irregularity); generally causes a bowel movement in 6-12 hours

    CLOSE

  • WARNINGS

    WARNINGS:

    Do not use this product
    If you are presently taking mineral oil unless directed by a doctor

    Laxative products for longer than 1 week unless directed by a doctor

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children. Incase of overdose, get medical help or contact a Poison Control Center right away.

  • PRINCIPAL DISPLAY PANEL

    48CT

  • INGREDIENTS AND APPEARANCE
    MAXIMUM STRENGTH LAXATIVE PILLS 
    sennosides tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11673-995
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    sennosides (UNII: 3FYP5M0IJX) (sennosides - UNII:3FYP5M0IJX) sennosides25 mg
    Inactive Ingredients
    Ingredient NameStrength
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    KAOLIN (UNII: 24H4NWX5CO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    RAW SUGAR (UNII: 8M707QY5GH)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE (UNII: FZ989GH94E)  
    SHELLAC (UNII: 46N107B71O)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    TALC (UNII: 7SEV7J4R1U)  
    ACACIA (UNII: 5C5403N26O)  
    Product Characteristics
    ColorblueScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code TCL083
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11673-995-4848 in 1 BLISTER PACK; Type 0: Not a Combination Product04/26/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33404/09/2019
    Labeler - TARGET CORPORATION (006961700)
    Registrant - TIME CAP LABORATORIES, INC. (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    TIME CAP LABORATORIES, INC.037052099manufacture(11673-995)