Label: SENNA SYRUP- sennosides liquid

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

Drug Label Information

Updated January 8, 2025

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  • Drug Facts

    Active Ingredient (in each 5 mL = 1 teaspoonful)
    Sennosides 8.8 mg

  • PURPOSE

    Purpose
    Laxative

  • INDICATIONS & USAGE

    Use: • relieves occasional constipation (irregularity), generally causes bowel movement in 6-12 hours.

  • WARNINGS

    WARNINGS: Do not use • laxative products for a period 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 movement that continues over a period of 2 weeks

  • STOP USE

    Stop use and ask a doctor if you have • rectal bleeding • no bowel movement after use of laxative

    These could be signs of a serious condition.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast feeding, ask a health care professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all drugs out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately. In case of eye contact, flush with water.

  • DOSAGE & ADMINISTRATION

    1 teaspoonful = 5 mL
    Directions:
    • Shake well before use
    • Do not exceed recommended dose
    AgeStarting DoseMaximum Dosage
    Adults and children 12 years of age and over2 to 3 teaspoonfuls (10 mL to 15 mL) once a day preferably at bedtime; increase as needed or as recommended by a doctor3 teaspoonfuls (15 mL) in the morning and 3 teaspoonfuls (15 mL) at bedtime
    Children under 12 years of age Ask a doctorAsk a doctor
  • STORAGE AND HANDLING

    Other information: Store at room temperature 15°C to 25°C (59°F to 77°F). Excursions between 26°C to 30°C (78°F to 86°F) are allowed. Protect from excessive heat. For more info call 1- 800-447-1006.

  • INACTIVE INGREDIENT

    Inactive ingredients: Artificial and natural chocolate flavor, methylparaben, propylparaben, propylene glycol, sucrose and purified water.

  • SPL UNCLASSIFIED SECTION

    NDC: 48433-219-05 Senna Syrup 8.8 mg/5 mL Unit Dose Cup

    Mfd. in the U.S.A.
    Distributed by: Safecor Health, LLC
    4060 Business Park Drive, Columbus, OH 43204                                                               Rev: 02/2020 PN5497

  • PRINCIPAL DISPLAY PANEL

    ———Principal Display Panel———

    SAFECOR HEALTH
                                                                                  NDC: 48433-219-40
    Senna Syrup                                                         Qty: 40
    8.8 mg Sennosides per 5 mL                                 Lot: 20A0020
    Contains 40 (5 mL) Unit Dose Cups                      Exp: 210203
    See monograph for complete drug information.
    Store at room temperature 15°C to 25°C (59°F to 77°F);
    excursions between 26°C to 30°C (78°F to 86°F) are allowed.
    Protect from excessive heat.
    This package design is not child resistant. For institutional use only.
    Shake well before use.
                                                                                         GTIN: 00348433219409
                                                                                         SN: 200600019
    Pkg By: Safecor Health, LLC Columbus, OH 43204   Exp: 210203
         Questions or Comments: Call 1-800-447-1006       Lot: 20A0020

    Box Label
    Unit Dose Cup Label
  • INGREDIENTS AND APPEARANCE
    SENNA SYRUP 
    sennosides liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48433-219(NDC:54859-808)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES8.8 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SUCROSE (UNII: C151H8M554)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:48433-219-4040 in 1 BOX03/01/2020
    1NDC:48433-219-055 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM33403/01/2020
    Labeler - Safecor Health, LLC (828269675)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safecor Health, LLC828269675repack(48433-219)
    Establishment
    NameAddressID/FEIBusiness Operations
    Llorens Pharmaceutical International Division, Inc.037342305manufacture(48433-219)
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