Label: SENNA SYRUP- sennosides liquid

  • NDC Code(s): 57237-310-05, 57237-310-54
  • Packager: Rising Health, 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 May 23, 2023

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  • ACTIVE INGREDIENT

    Senna Syrup (8.8 mg/5 mL)

    Active ingredient per 5 mL(1 Unit Dose) Sennosides 8.8 mg

  • PURPOSE

    Drug Facts

    Purpose

    Laxative

  • INDICATIONS & USAGE

    Uses

    • relieves occasional constipation (irregularity)
    • generally causes bowel movement in 6 to 12 hours
  • WARNINGS

    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, or vomiting
    • noticed a change in bowel habits that lasts over two weeks

    Stop use and ask a doctor if you have rectal bleeding or failure to have a bowel movement after use of laxative. These may indicate a serious condition.

  • PREGNANCY

    If pregnant or breast-feeding, ask a healthcare professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)

  • DOSAGE & ADMINISTRATION

    Directions

    • shake well before use
    • do not exceed recommended dose
    AgeStarting DoseMaximum Dose
    Adults and children over 12 years of age10 to 15 mL once a day at bedtime, increase as needed or as directed by a doctor15 mL in the morning and 15 mL at bedtime
    Children under 12 years of age Ask a doctorAsk a doctor

  • Other information

    • store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]
    • do not use if lid is torn or broken

  • INACTIVE INGREDIENT

    Inactive ingredients flavor, methylparaben, propylene glycol, propylparaben, purified water, and sucrose.

  • QUESTIONS

    Questions or comments? Call 1-844-474-7464

  • PRINCIPAL DISPLAY PANEL

    Distributed by:

    Rising Pharma Holdings, Inc.

    East Brunswick, NJ 08816

    FG-38/Iss.: 04/2023

    Lid Label

    senna-lid-label

    Case Label

    senna-case-label

  • INGREDIENTS AND APPEARANCE
    SENNA SYRUP 
    sennosides liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57237-310
    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)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHOCOLATEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57237-310-5440 in 1 BOX05/23/2023
    1NDC:57237-310-055 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 finalpart33405/23/2023
    Labeler - Rising Health, LLC (080500961)
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