Label: LAXATIVE- sennosides, 25 mg tablet, film coated

  • NDC Code(s): 63561-0186-9
  • Packager: Granulation Technology, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 17, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)
    Sennosides, 25 mg

  • PURPOSE

    Purpose

    Stimulant Laxative

  • Uses

    • Relieves occasional constipation (irregularity)
    • Generally produces a bowel movement in 6-12 hours
  • Warnings

  • DO NOT USE

    Do not uselaxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor.

  • ASK DOCTOR

    Ask a doctor before use if you havenoticed a sudden change in bowel habits that persists over a period of 2 weeks.

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you aretaking any other drug. Laxatives may affect how other drugs work. Take this product 2 or more hours before or after other drugs.

  • WHEN USING

    When using this productdo not use for a period longer than 1 week.

  • STOP USE

    Stop use and ask a doctor ifrectal bleeding or failure to have a bowel movement occur after use of a laxative. These may be signs of 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).

  • Directions

    • swallow tablet (s) with a glass of water.
    • swallow tablet (s) whole, do not crush, break, or chew.
    AgeDosage
    adults and children 12 years of age and over2 tablets once or twice daily
    children 6 to under 12 years1 tablet once a day or twice daily
    children under 6 yearsAsk a doctor

  • Other information

    • Each tablet contains:Calcium 40 mg, Magnesium 5 mg
    • Store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • Use by expiration date on package
  • Inactive ingredients

    croscarmellose sodium,dibasic calcium phosphate dihydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol (PEG) 3350, talc, yellow iron oxide, FD&C blue 1 lake

  • QUESTIONS

    Questions or comments?


    call 1-973-276-0740

  • Principal Display Panel

    NDC 63561-0186-9

    Laxative Tablets Label

    SENNOSIDES, 25 mg / STIMULANT LAXATIVE

    Compare to ex.lax ® Maximum Strength Active Ingredient

    90 Film-Coated Tablets

    Sennosides 25 mg

    Sennosides 25 mg_peel

  • INGREDIENTS AND APPEARANCE
    LAXATIVE 
    sennosides, 25 mg tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63561-0186
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES25 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
    TALC (UNII: 7SEV7J4R1U)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
    Product Characteristics
    ColorblueScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code G186
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63561-0186-990 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/17/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)12/17/2024
    Labeler - Granulation Technology, Inc. (847132193)
    Registrant - Granulation Technology, Inc. (847132193)
    Establishment
    NameAddressID/FEIBusiness Operations
    Granulation Technology, Inc.847132193manufacture(63561-0186)
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