Label: ONLY FOR STIMULANT LAXATIVE- sennosides tablet

  • 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 April 25, 2019

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  • DRUG FACTS

  • Active ingredient (in each tablet)

    Sennosides 8.6 mg

  • Purpose

    Stimulant laxative

  • Uses:

    • relieves occasional constipation (irregularity)

    • generally causes a bowel movement in 6‐12 hours

  • Warnings:

    Do not use:

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

    Ask a doctor before use if you have

    • stomach pain

    • nausea

    • vomiting

    • noticed a sudden change in bowel habits that continue over a period of 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 accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions:

    • do not take more than directed  • take with full glass of water

    • take preferably at bedtime or as directed by a doctor

     AgeStarting dosage Maximum dosage 
                        adults and children 12 years of age and over  2 tablets once a day 4 tablets twice a day
                        children 6 to under 12 years 1 tablet once a day 2 tablets twice a day
                        children 2 to under 6 years 1/2 tablet once a day 1 tablet twice a day
                        children under 2 years       ask a doctor       ask a doctor

  • Other Information:

    • Store at room temperature between 20-25°C (68-77°F).

  • Inactive Ingredients:

    Croscarmellose sodium, dibasic calcium phosphate, hydroxypropyl methyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol.

  • Questions Or Comments ?

    1-833-665-9444.

  • SPL UNCLASSIFIED SECTION

    Distributed By: O4 GLOBAL TRADING USA LLC., 2241 S Watson RD, Suite 121 Arlington, TX 76010.

    www.onlyfor.com

    Packaged By: Strive Pharmaceuticals Inc., East Brunswick, NJ 08816

    TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF A BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGN OF TAMPERING

    Tear along perforation push product through foil

    CT2LXN4-REV.102018

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    ONLY FOR  STIMULANT LAXATIVE
    sennosides tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73006-112
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES8.6 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
    MAGNESIUM PALMITOSTEARATE (UNII: R4OXA9G5BV)  
    MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    Product Characteristics
    ColorbrownScoreno score
    ShapeROUND (Biconvex) Size9mm
    FlavorImprint Code S3
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73006-112-411 in 1 CARTON03/29/2019
    14 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33403/29/2019
    Labeler - O4 Global Trading Usa, Llc (081226861)
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