Label: GERI-KOT- sennosides tablet

  • NDC Code(s): 57896-415-01, 57896-415-10, 57896-415-20
  • Packager: Geri-Care Pharmaceutical Corp
  • 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 December 28, 2022

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  • Active ingredient (in each tablet)

    Sennosides 8.6 mg

  • Purpose

    Laxative

  • Uses

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

    Do not use

    for more than 1 week unless directed by a doctor.

    Ask a doctor before use if you
    • have abdominal pain, nausea or vomiting
    • have noticed a sudden change in bowel habits that lasts over 2 weeks
    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.
    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.

  • Directions

    • do not exceed 8 tablets in 24 hours

    Age
    		Starting Dose
    		Maximum Dose
    adults and children 12 years of age and older
    		2 tablets once a day preferably at bedtime; increase as needed, or as directed by a doctor
    		4 tablets in the morning and 4 tablets at bedtime
    children under 12 years
    		ask a doctor



  • Other information

    • each tablet contains: calcium 30 mg
    • Tamper Evident: Do not use if imprinted seal under cap is missing or broken
    • store at 20°C-25°C (68°F-77°F)
  • Inactive ingredients

    croscarmellose sodium, dicalcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, silica, talc, triacetin

  • Package Label

    1

  • INGREDIENTS AND APPEARANCE
    GERI-KOT 
    sennosides tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57896-415
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES8.6 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TALC (UNII: 7SEV7J4R1U)  
    TRIACETIN (UNII: XHX3C3X673)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    Product Characteristics
    ColorbrownScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code PS23
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57896-415-01100 in 1 BOTTLE; Type 0: Not a Combination Product12/01/2022
    2NDC:57896-415-101000 in 1 BOTTLE; Type 0: Not a Combination Product12/01/2022
    3NDC:57896-415-20200 in 1 BOTTLE; Type 0: Not a Combination Product12/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33412/01/2022
    Labeler - Geri-Care Pharmaceutical Corp (611196254)
    Registrant - Geri-Care Pharmaceutical Corp (611196254)
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