Label: GERI-KOT- standardized senna concentrate tablet

  • NDC Code(s): 57896-454-01, 57896-454-10, 57896-454-20
  • 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 November 14, 2018

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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 40 mg
    • Tamper Evident: Do not use if imprinted seal under cap is missing or broken
    • store at room temperature
  • Inactive ingredients

    cellulose, croscarmellose sodium,
    dicalcium phosphate, hypromellose*, magnesium silicate*,
    magnesium stearate, mineral oil*, PEG*, silica*, wax*.
    *May contain these ingredients

  • Package Label

    454

  • INGREDIENTS AND APPEARANCE
    GERI-KOT 
    standardized senna concentrate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57896-454
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES8.6 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    MAGNESIUM SILICATE (UNII: 9B9691B2N9)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    Product Characteristics
    ColorbrownScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code AZ217
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57896-454-01100 in 1 BOTTLE; Type 0: Not a Combination Product08/01/2018
    2NDC:57896-454-101000 in 1 BOTTLE; Type 0: Not a Combination Product04/01/2018
    3NDC:57896-454-20200 in 1 BOTTLE; Type 0: Not a Combination Product08/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33404/01/2018
    Labeler - Geri-Care Pharmaceutical Corp (611196254)
    Registrant - Geri-Care Pharmaceutical Corp (611196254)
    Establishment
    NameAddressID/FEIBusiness Operations
    Geri-Care Pharmaceutical Corp611196254repack(57896-454)
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