Label: SENNA TIME- sennosides tablet, coated

  • 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 10, 2022

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  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)
    Sennosides 8.6 mg

  • 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

  • PURPOSE

    Purpose
    Laxative

  • INDICATIONS & USAGE

    Uses

    • 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 dayChildren 6 to under 12 years - starting dosage: 1 tablet once a day Maximum dosage: 2 tablets twice a dayChildren 2 to under 6 years - starting dosage: 1/2 tablet once a day Maximum dosage: 1 tablet twice a dayChildren under 2 years - ask a doctor

  • WARNINGS

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

  • ASK DOCTOR

    Ask a doctor before use if you have

    • stomach pain
    • nausea
    • vomiting
    • noticed a sudden change in bowel movements that continues over a period of 2 weeks
  • INACTIVE INGREDIENT

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

  • HOW SUPPLIED

    NDC: 71335-0865-1 100 TABLET in a BOTTLE

    NDC: 71335-0865-2 60 TABLET in a BOTTLE

    NDC: 71335-0865-3 120 TABLET in a BOTTLE

    NDC: 71335-0865-4 56 TABLET in a BOTTLE

    NDC: 71335-0865-5 30 TABLET in a BOTTLE

    NDC: 71335-0865-6 90 TABLET in a BOTTLE

  • Sennosides 8.6mg Tablet

    Label Image
  • INGREDIENTS AND APPEARANCE
    SENNA TIME 
    sennosides tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71335-0865(NDC:49483-080)
    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
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    Product Characteristics
    ColorbrownScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code TCL080
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71335-0865-1100 in 1 BOTTLE; Type 0: Not a Combination Product06/16/2017
    2NDC:71335-0865-260 in 1 BOTTLE; Type 0: Not a Combination Product06/16/2017
    3NDC:71335-0865-3120 in 1 BOTTLE; Type 0: Not a Combination Product06/16/2017
    4NDC:71335-0865-456 in 1 BOTTLE; Type 0: Not a Combination Product06/16/2017
    5NDC:71335-0865-530 in 1 BOTTLE; Type 0: Not a Combination Product06/16/2017
    6NDC:71335-0865-690 in 1 BOTTLE; Type 0: Not a Combination Product06/16/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33405/14/2012
    Labeler - Bryant Ranch Prepack (171714327)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bryant Ranch Prepack171714327REPACK(71335-0865) , RELABEL(71335-0865)
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