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 13, 2023

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  • Drug Facts

    Active Ingredient (in each 15 mL = 3 teaspoonful) Sennosides 26.4 mg

  • 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

    Directions:
    • Shake well before use • Do not exceed recommended dose

    Age

    Dose

    Adults and children 12 years of age and over15 – 30 mL up to 2 times a day
    Children under 12 years of ageAsk a doctor

    3 teaspoon = 15 mL

  • 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: 48433-222-15 Senna Syrup 26.4 mg/15 mL Unit Dose Cup
    NDC: 48433-222-40 Box of 40 Unit-Dose Cups, each unit-dose cup delivers 15 mL

    For Oral Use Only.
    For Institutional Use Only.
    This Package Is Not Child Resistant.

    Packaged By:
    Safecor Health, LLC
    4060 Business Park Drive
    Columbus, OH 43204

    05/2023 PN5737

  • PRINCIPAL DISPLAY PANEL

    ———Principal Display Panel Box Label———

    SAFECOR HEALTH
                                                                                  NDC: 48433-222-40
    Senna Syrup                                                         Qty: 40
    26.4 mg Sennosides per 15 mL                           Lot: 23A0081
    Contains 40 (15 mL) Unit Dose Cups                       Exp: 2025-07-31
    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: 233000041
    Pkg By: Safecor Health, LLC Columbus, OH 43204           Exp: 2025-07-31
         Questions or Comments: Call 1-800-447-1006           Lot: 23A0081

    ———Principal Display Panel Unit Dose Cup Label———

    Delivers 15 mL

    NDC 48433-222-15

    Senna Syrup

    Each 15 mL Contains:

    Sennosides 26.4 mg

    SHAKE WELL

    348433222157

    Pkg By: Safecor Health, LLC

    Columbus, OH 43204

    PN5923.A

    Box Label
    Unit Dose Cup Label
  • INGREDIENTS AND APPEARANCE
    SENNA SYRUP 
    sennosides liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48433-222(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:48433-222-4040 in 1 BOX08/07/2023
    1NDC:48433-222-1515 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 finalpart33408/07/2023
    Labeler - Safecor Health, LLC (828269675)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safecor Health, LLC828269675repack(48433-222)
    Establishment
    NameAddressID/FEIBusiness Operations
    Llorens Pharmaceutical International Division, Inc.037342305manufacture(48433-222)
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