Label: LAXATIVE- sennosides tablet

  • NDC Code(s): 0363-9978-24, 0363-9978-48, 0363-9978-90
  • Packager: WALGREENS
  • 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 19, 2023

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  • Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)
    Sennosides USP, 25 mg

  • PURPOSE

    Purpose
    Stimulant laxative

  • INDICATIONS & USAGE

    Uses
    • relieves occasional constipation (irregularity)
    • generally produces bowel movement in 6 to 12 hours

  • 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 (1-800-222-1222).

  • 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: 2 tablets once or twice daily
    children 6 to under 12 years of age: 1 tablet once or twice daily
    children under 6 years of age: ask a doctor

  • STORAGE AND HANDLING

    Other information
    • each tablet contains: calcium 40 mg, sodium 2 mg (VERY LOW SODIUM)
    • store between 20°-25°C (68°-77°F)

  • INACTIVE INGREDIENT

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

  • QUESTIONS

    Questions or comments?
    call 1-877-290-4008

  • PRINCIPAL DISPLAY PANEL

    195R-WG-Laxative-90s-label195R-WG-Laxative-48s-ifc195R-WG-Laxative-24s-ifc

  • INGREDIENTS AND APPEARANCE
    LAXATIVE 
    sennosides tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-9978
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES25 mg
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    KAOLIN (UNII: 24H4NWX5CO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    RAW SUGAR (UNII: 8M707QY5GH)  
    TALC (UNII: 7SEV7J4R1U)  
    ACACIA (UNII: 5C5403N26O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    POVIDONE (UNII: FZ989GH94E)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SHELLAC (UNII: 46N107B71O)  
    Product Characteristics
    ColorblueScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code TCL083
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-9978-484 in 1 CARTON04/15/2023
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0363-9978-242 in 1 CARTON04/15/2023
    212 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:0363-9978-9090 in 1 BOTTLE; Type 0: Not a Combination Product04/15/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33404/15/2023
    Labeler - WALGREENS (008965063)
    Registrant - TIME CAP LABORATORIES INC. (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    TIME CAP LABORATORIES INC.037052099manufacture(0363-9978)
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