Label: SENNA SYRUP- sennosides liquid

  • 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 August 7, 2023

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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 not finalpart33403/01/2020
    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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