Label: SENNA SYRUP- sennosides liquid

  • NDC Code(s): 0121-4967-05, 0121-4967-40
  • Packager: Pharmaceutical Associates, Inc.
  • 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 September 1, 2022

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredient (per teaspoonful - 5 mL)

    Sennosides - 8.8 mg

  • PURPOSE

    Purpose

    Laxative

  • INDICATIONS & USAGE

    Uses

    • relieves occasional constipation (irregularity)
    • generally causes bowel movment 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 or pharmacist before use if you have

    • stomach pain
    • nausea
    • vomiting
    • noticed a sudden changed in bowel movement that continues over a period of 2 weeks

    Stop use and ask a doctor if

    you have rectal bleeding or failure to have a bowel movemebt after use of laxative. They may indicate a serious condition.

  • PREGNANCY

    If pregnant or breast-feeding ask a health 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 (1-800-222-1222) immediately.

  • DOSAGE & ADMINISTRATION

    • shake well before use
    • Do not exceed recommended dose
    AgeStarting Dose Maximum dosage
     Adults and children 12 years and older 2-3 teaspoonfuls once a day preferably at bedtime; increase as needed or as recommended by a doctor3 teaspoons in the morning and 3 teaspoons at bedtime
    Under 12 years of age ask a doctor ask a doctor

    Other information

    • store at room temperature 20° to 25°C (68° to 77°F).
    • a brown, natural flavored syrup supplied in the following oral dosage form:

    NDC 0121-4967-05: 5 mL unit dose cup, in a tray of ten cups.
    NDC 0121-4967-40: Case contains 40 unit dose cups of 5 mL (0121-4967-05) packaged in 4 trays of 10 unit dose cups each.

  • INACTIVE INGREDIENT

    Inactive ingredients: citric acid, glycerin, methylparaben, potassium sorbate, propylparaben, purified water, and sucrose.

  • QUESTIONS

    Questions or comments? 1-800-845-8210

    Distributed By:

    Pharmaceutical Associates, Inc.

    Greenville, SC 29605

  • PRINCIPAL DISPLAY PANEL

    Delivers 5 mL
    NDC 0121-4967-05

    Senna Syrup

    8.8 mg Sennosides/5 mL

    Natural Vegetable Laxative

    Package Not Child-Resistant

    Pharmacutical Associates, Inc.
    Greenville, SC 29605

    SEE DRUG FACTS

    image description

  • INGREDIENTS AND APPEARANCE
    SENNA SYRUP 
    sennosides liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0121-4967
    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
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SUCROSE (UNII: C151H8M554)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0121-4967-404 in 1 CASE03/22/2022
    110 in 1 TRAY
    1NDC:0121-4967-055 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 finalpart33403/22/2022
    Labeler - Pharmaceutical Associates, Inc. (044940096)
    Registrant - Pharmaceutical Associates, Inc. (097630693)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharmaceutical Associates, Inc.097630693manufacture(0121-4967) , label(0121-4967)