Label: LEADER REGULAR STRENGTH CHOCOLATE LAXATIVE SENNOSIDES- sennosides tablet

  • 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 January 25, 2021

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

  • Active ingredient (in each piece)

    Sennosides, 15 mg

  • Purpose

    Stimulant laxative

  • Uses

    • relieves occasional constipation (irregularity)
    • generally produces bowel movement in 6 to 12 hours
  • Warnings

    Do not use laxative products when abdominal pain, nausea or vomiting are present unless directed by a doctor

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

    Ask a doctor or pharmacist before use if you are taking any other drug. Laxatives may affect how other drugs work. Take this product 2 or more hours before or after other drugs.

    When using this product do not use for a period longer than 1 week

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

    If pregnant or breastfeeding, 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 (1-800-222-1222) right away.

  • Directions

    adults and children 12 years of age and olderchew 2 chocolated pieces once or twice daily
    children 6 to under 12 years of agechew 1 chocolated piece once or twice daily
    children under 6 years of ageask a doctor
  • Other information

    • each piece contains: potassium 10 mg
    • store at 15°-25°C (59°-77°F)
  • Inactive ingredients

    cocoa powder, hydrogenated vegetable oils (palm, palm kernel), salt, soy lecithin (an emulsifier), sugar, vanilla, and whey powder (milk)

  • Questions or comments?

    1-877-586-7979

  • Principal Display Panel – Chocolated Laxative Carton Label

    LEADER™

    NDC 70000-0477-1

    Regular Strength

    Chocolated
    Laxative

    Sennosides, USP, 15 mg | Stimulant Laxative

    Chocolate
    Flavored

    Relieves Occasional
    Constipation

    24 pieces

    Actual Size

    COMPARE TO
    ex•lax
    ®
    REGULAR
    STRENGTH
    active ingredient*

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    Principal Display Panel – Chocolated Laxative Carton Label
  • INGREDIENTS AND APPEARANCE
    LEADER REGULAR STRENGTH CHOCOLATE LAXATIVE SENNOSIDES 
    sennosides tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0477
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sennosides (UNII: 3FYP5M0IJX) (Sennosides - UNII:3FYP5M0IJX) Sennosides15 mg
    Inactive Ingredients
    Ingredient NameStrength
    Cocoa (UNII: D9108TZ9KG)  
    Product Characteristics
    Colorbrown (brown) Scorescore with uneven pieces
    ShapeSQUARE (square) Size68mm
    FlavorCHOCOLATE (chocolate) Imprint Code CL
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0477-12 in 1 CARTON01/01/2019
    112 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33401/01/2019
    Labeler - Cardinal Health Inc. (097537435)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aphena Pharma Solutions MD, LLC829739833MANUFACTURE(70000-0477)