Label: VEGETABLE LAXATIVE- sennosides tablet

  • NDC Code(s): 21130-998-01
  • Packager: BETTER LIVING BRANDS LLC.
  • 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 June 12, 2023

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  • Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)

    Sennosides 8.6 mg

  • PURPOSE

    Purpose

    Laxative

  • INDICATIONS & USAGE

    Uses

    • relieves occasional constipation (irregularity)
    • generally produces bowel movement in 6-12 hours
  • WARNINGS

    Warnings

  • DO NOT USE

    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 habits that continues over a period of 2 weeks
  • STOP USE

    Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate a serious condition.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • 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 (1-800-222-1222).

  • DOSAGE & ADMINISTRATION

    Directions

    • take preferably at bedtime or as directed by a doctor

    age

    		starting dosagemaximum dosage
    adults and children 12 years of age and over

    2 tablets once a day

    		4 tablets twice a day
    children 6 to under 12 years

    1 tablet once a day

    2 tablets twice a day
    children 2 to under 6 years

    ½ tablet once a day

    		1 tablet twice a day
    children under 2 yearsask a doctorask a doctor

  • OTHER SAFETY INFORMATION

    Other information

    • each tablet contains: calcium 25 mg, sodium 2 mg (VERY LOW SODIUM)
    • store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
  • INACTIVE INGREDIENT

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

  • QUESTIONS

    Questions or comments?1-877-290-4008

  • PRINCIPAL DISPLAY PANEL

    191R_Albertsons_IFC_100ct191R_Albertsons_lbl_100ct

  • INGREDIENTS AND APPEARANCE
    VEGETABLE LAXATIVE 
    sennosides tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-998
    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)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorbrownScoreno score
    ShapeROUND (Round, biconvex tablets) Size9mm
    FlavorImprint Code TCL080
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21130-998-011 in 1 CARTON06/12/2023
    1100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33406/12/2023
    Labeler - BETTER LIVING BRANDS LLC. (009137209)
    Registrant - TIME CAP LABORATORIES, INC. (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    TIME CAP LABORATORIES, INC.037052099manufacture(21130-998)
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