Label: GERI-KOT- standardized senna concentrate tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 19, 2024

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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

  • HOW SUPPLIED

    NDC: 71335-1806-1: 100 Tablets in a BOTTLE

    NDC: 71335-1806-2: 60 Tablets in a BOTTLE

    NDC: 71335-1806-3: 120 Tablets in a BOTTLE

    NDC: 71335-1806-4: 56 Tablets in a BOTTLE

    NDC: 71335-1806-5: 30 Tablets in a BOTTLE

    NDC: 71335-1806-6: 90 Tablets in a BOTTLE

    NDC: 71335-1806-7: 10 Tablets in a BOTTLE

    Repackaged/Relabeled by:
    Bryant Ranch Prepack, Inc.
    Burbank, CA 91504

  • PRINCIPAL DISPLAY PANEL

    Sennosides 8.6mg Tablet

    Label
  • INGREDIENTS AND APPEARANCE
    GERI-KOT 
    standardized senna concentrate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71335-1806(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)  
    MICROCRYSTALLINE CELLULOSE (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
    ColorbrownScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code AZ217
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71335-1806-1100 in 1 BOTTLE; Type 0: Not a Combination Product02/24/2022
    2NDC:71335-1806-260 in 1 BOTTLE; Type 0: Not a Combination Product02/24/2022
    3NDC:71335-1806-3120 in 1 BOTTLE; Type 0: Not a Combination Product02/24/2022
    4NDC:71335-1806-456 in 1 BOTTLE; Type 0: Not a Combination Product02/24/2022
    5NDC:71335-1806-530 in 1 BOTTLE; Type 0: Not a Combination Product02/24/2022
    6NDC:71335-1806-690 in 1 BOTTLE; Type 0: Not a Combination Product02/24/2022
    7NDC:71335-1806-710 in 1 BOTTLE; Type 0: Not a Combination Product02/24/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)04/01/2018
    Labeler - Bryant Ranch Prepack (171714327)
    Registrant - Bryant Ranch Prepack (171714327)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bryant Ranch Prepack171714327REPACK(71335-1806) , RELABEL(71335-1806)
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