Label: LITTLE REMEDIES LITTLE TUMMYS LAXATIVE DROPS- 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 September 22, 2012

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    (in each 1.0 mL)

    Sennosides 8.8 mg

  • Purpose

    Stimulant Laxative

  • Uses

  • Warnings

    Do not give laxative products to your child for a period longer than 1 week unless directed by a doctor

  • Ask a doctor before use if your child has

    • Stomach pain
    • Nausea
    • Vomiting
    • A sudden change in bowel movements that continues over a period of 2 weeks
  • Stop use & ask a doctor if

    your child has rectal bleeding or failure to have a bowel movement after use of a laxative. These symptoms may indicate a serious condition.

  • Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control center right away.

  • Directions

  • Other information

  • Inactive ingredients      

    ascorbic acid, natural chocolate flavor, methyl paraben, polysorbate 20, potassium sorbate, propyl gallate, propylene glycol, purified water, sorbitol, soya lecithin, sucralose

  • Questions?

    For further information you may contact us at: 1-800-7-LITTLE Monday–Friday 8:00 a.m. to 8:00 p.m. EST, or visit us online at www.LittleRemedies.com

    This Little Remedies® product has been specially formulated to provide small concentrated doses for easier administration.

    For accurate dosing; only use the enclosed dropper and follow all dosing instructions.

  • PRINCIPAL DISPLAY PANEL

    Medicated for Kids 2+

    Little Tummys® 

    by Little

    Remedies® 

    STIMULANT

    LAXATIVE

    DROPS

    Safe, Gentle & Effective

    Relief of Constipation

    Free of Alcohol, Saccharin & Dyes

    Natural Chocolate Flavor

    Concentrated Oral Drops

    Up to 60 Doses

    1 FL. OZ. 

    (30 mL)

    PRINCIPAL DISPLAY PANEL Medicated for Kids 2+ Little Tummys® by Little Remedies® STIMULANT LAXATIVE DROPS Safe, Gentle & Effective Relief of Constipation Free of Alcohol, Saccharin & Dyes Natural Chocolate Flavor Concentrated Oral Drops Up to 60 Doses 1 FL. OZ. (30 mL)

  • INGREDIENTS AND APPEARANCE
    LITTLE REMEDIES LITTLE TUMMYS LAXATIVE DROPS 
    sennosides liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-424
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES8.8 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorBROWNScore    
    ShapeSize
    FlavorCHOCOLATEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63029-424-011 in 1 BOX
    130 mL in 1 BOTTLE, DISPENSING
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart33406/01/2010
    Labeler - Medtech Products Inc. (122715688)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!