Label: GERI-KOT- standardized senna concentrate tablet

  • Category: HUMAN OTC DRUG LABEL

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 17, 2019

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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 no bowel movement  within 12 hours
    • you have rectal bleeding 
    These could 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.

  • 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 20 mg
    • store at room temperature

    This Product was Repackaged By:

    DOH CENTRAL PHARMACY
    104 HAMILTON PARK DR # 2
    TALLAHASSEE, FL 32304
    USA

  • Inactive ingredients

    cellulose, croscarmellose sodium, dicalcium phosphate, hypromellose, magnesium silicate, magnesium stearate, mineral oil, PEG.

  • PACKAGE LABEL

    Label Image for 53808-1110
    8.6mg

    Label Image for 8.6mg
  • INGREDIENTS AND APPEARANCE
    GERI-KOT  
    standardized senna concentrate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53808-1110(NDC:57896-451)
    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)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    MAGNESIUM SILICATE (UNII: 9B9691B2N9)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    Product Characteristics
    ColorBROWN (light brown) Scoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code 1122
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53808-1110-130 in 1 BLISTER PACK; Type 0: Not a Combination Product01/09/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart33401/09/2018
    Labeler - DOH CENTRAL PHARMACY (829348114)
    Establishment
    NameAddressID/FEIBusiness Operations
    DOH CENTRAL PHARMACY829348114repack(53808-1110)
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