Label: SENNA LAXATIVE- sennosides 8.6 mg 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

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  • ACTIVE INGREDIENTS

    EACH TABLET CONTAINS: SENNOSIDES 8.6 MG

  • INACTIVE INGREDIENTS

    croscarmellose sodium, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil

  • PURPOSE

    LAXATIVE

  • INDICATIONS & USAGE

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

  • 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 (do not 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 2 to under 6 years - starting dosage: 1/2 tablet once a day Maximum dosage: 1 tablet twice a day

    Children under 2 years - ask a doctor

  • KEEP OUT OF REACH OF CHILDREN

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

  • WARNINGS

    Do not use laxative products for longer than 1 week unless directed by a doctor

  • PRINCIPAL DISPLAY PANEL

    191R BOX

  • INGREDIENTS AND APPEARANCE
    SENNA LAXATIVE 
    sennosides 8.6 mg tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11673-191
    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 B8.6 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    CROSCARMELLOSE (UNII: 029TFK992N)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    Product Characteristics
    ColorbrownScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code TCL080
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11673-191-01100 in 1 BOTTLE; Type 0: Not a Combination Product04/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33404/01/2019
    Labeler - TARGET CORPORATION (006961700)
    Registrant - TIME CAP LABORATORIES, INC. (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    TIME CAP LABORATORIES INC037052099manufacture(11673-191)