Label: REGULAR STRENGTH LAXATIVE- sennosides 15 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 January 8, 2022

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

View All Sections
  • DRUG FACTS

  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)

    Sennosides USP, 15 mg

  • PURPOSE

    Purpose

    Stimulant Laxative

  • INDICATIONS & USAGE

    Uses
    • relieves occasional constipation (irregularity)
    • generally produces bowel movement in 6 to12 hours

  • WARNINGS

    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 any other 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 right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • Swallow tablet(s) with a glass of water
    • Swallow tablet(s) whole, do not crush, break, or chew.

    adults and children 12 years of age and older take 2 tablets once or twice daily
    children 6 to under 12 years of age take 1 tablet once or twice daily
    children under 6 years of age ask a doctor

  • OTHER SAFETY INFORMATION

    Other information
    • each tablet contains: calcium 50 mg, sodium 2 mg (VERY LOW SODIUM)
    • store between 20°-25°C (68°-77°F)

  • INACTIVE INGREDIENT

    Inactive ingredient acacia, calcium sulfate anhydrous, carnauba wax, corn starch, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, iron oxide, iron oxide black, iron oxide yellow, kaolin, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol (PEG) 400, povidone, shellac, sugar, talc, titanium dioxide

  • QUESTIONS

    Questions? Call 1-800-824-1706
    Monday – Friday 9am – 4pm MST

  • PRINCIPAL DISPLAY PANEL

    190R-Winco-Regular-strength-carton-24s

  • INGREDIENTS AND APPEARANCE
    REGULAR STRENGTH LAXATIVE 
    sennosides 15 mg tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67091-384
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES15 mg
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SHELLAC (UNII: 46N107B71O)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    RAW SUGAR (UNII: 8M707QY5GH)  
    ACACIA (UNII: 5C5403N26O)  
    KAOLIN (UNII: 24H4NWX5CO)  
    TALC (UNII: 7SEV7J4R1U)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code TCL079
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67091-384-241 in 1 CARTON01/14/2022
    124 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33401/14/2022
    Labeler - WinCo Foods LLC (056098817)
    Registrant - TIME CAP LABORATORIES, INC. (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    TIME CAP LABORATORIES, INC.037052099manufacture(67091-384)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!