Label: SENNA- sennosides syrup

  • 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 3, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each 5 ml teaspoonful)

    Sennosides 8.8 mg

  • PURPOSE

    Purpose

    Laxative

  • INDICATIONS & USAGE

    Uses

    • relieves occasional constipation (irregularity)
    • when abdominal pain, nausea or vomiting are present
  • WARNINGS

    Warnings

    Do not use

    • longer than 1 week unless directed by a doctor
    • when abdominal pain, nausea or vomiting are present

    Ask a doctor before use if you have noticed a sudden change in bowel movements that continues over a period of 2 weeks

    Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

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

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

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

  • DOSAGE & ADMINISTRATION

    Directions Take preferably at bedtime or as directed by a doctor. Shake well before using. Do not exceed recommended dose.

    AgeStarting DosageMaximum Dosage

    Adults and children

    12 years and older

    		2-3 teaspoons once a day3 teaspoons twice a day
    Under 12 years of ageask a doctorask a doctor

  • STORAGE AND HANDLING

    Other information

    • avoid excessive heat
    • store at room temperature 15°-25°C (59°-86°F).
    • Tamper-evident: do not use if aluminum foil seal over bottle opening is torn, broken or missing.

  • INACTIVE INGREDIENT

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

  • SPL UNCLASSIFIED SECTION

    Distributed by:

    Reliable-1 Laboratories LLC

    Valley Stream, NY 11580

    www.reliable1labs.com

    516-341-0666 Mon-Fri 8:30am-4:30pm

  • PRINCIPAL DISPLAY PANEL

    NDC 69618-069-58

    Reliable-1®

    Senna Syrup

    Natural Vegetable Laxative

    For Gentle Relief of Constipation

    Alcohol Free

    Natural Chocolate Flavor

    8 fl. oz. (237 ml)

    Senna Syrup-Final

  • INGREDIENTS AND APPEARANCE
    SENNA 
    sennosides syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69618-069
    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
    SUCROSE (UNII: C151H8M554)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Product Characteristics
    ColorbrownScore    
    ShapeSize
    FlavorCHOCOLATEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69618-069-58237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/03/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33408/03/2021
    Labeler - Reliable 1 Laboratories LLC (079718111)
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