Label: SENNA- sennosides tablet

  • NDC Code(s): 69618-048-01
  • Packager: Reliable 1 Laboratories LLC
  • 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 March 29, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients (in each tablet)

    Sennosides 8.6 mg

  • Purpose

    Stimulant Laxative

  • Uses

    • relieves occasional constipation (irregulatiry)
    • generally causes bowel movement in 6-12 hours
  • Warnings

    Do not use

    • laxative products for longer than 1 week unless directed by a doctor
  • ASK DOCTOR

    Ask a doctor before use if you have

    • stomach pain
    • nausea
    • vomiting
    • noticed a sudden change in bowel movements that continues over a period of 2 weeks
  • STOP USE

    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.

  • 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 children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    • take preferably at bedtime or as directed by a doctor
    • if you do not have a comfortable bowel movement by the second day, increase dose by one tablet (do not exceed maximum dosage) or decrease does until you are comfortable

    Agestarting dosagemaximum dosage
    adults children 12 years and over2 tablets once a day4 tablets twice a day
    children 6 to under 12 years1 tablet once a day2 tabelts twice a day
    children 2 to under 6 years1/2 tablet once a day1 tablet twice a day
    children under 2 yearsask a doctorask a doctor

  • Other information

    • each tablet contains: calcium 25 mg, sodium 2 mg (VERY LOW SODIUM)
    • store at 25°c (77°F) excursions permitted between 15°-30°C (59°-86°F)
  • Inactive ingredients

    croscarmellose sodium, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil

  • Questions or comments?

    Call 516-341-0666, 8:30 am - 4:30 pm ET, Monday - Friday

  • PRINCIPAL DISPLAY PANEL

    NDC 69618-018-01

    Reliable-1® LABORATORIES

    Micro-Coated

    Senna

    Sennosides 8.6 mg

    (standardized senna concentrate)

    NATURAL VEGETABLE LAXATIVE

    100 TABLETS

    *Compare to the Active Ingredient in SENOKOT®

    Senna

  • INGREDIENTS AND APPEARANCE
    SENNA 
    sennosides tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69618-048
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SENNOSIDES A AND B (UNII: 1B5FPI42EN) (SENNOSIDES A AND B - UNII:1B5FPI42EN) SENNOSIDES A AND B8.6 mg
    Inactive Ingredients
    Ingredient NameStrength
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    Product Characteristics
    ColorbrownScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code TCL;080
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69618-048-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33408/01/2018
    Labeler - Reliable 1 Laboratories LLC (079718111)
    Registrant - Reliable 1 Laboratories LLC (079718111)
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