Label: CHOCOLATED LAXATIVE- sennosides stimulant laxative tablet, chewable

  • 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 February 9, 2023

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  • Active ingredient (in each piece of 12 piece block)

    Sennosides, USP, 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 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.

  • Directions

    ​​​

    adults and children 12 years of age and older
    • chew 2 chocolated pieces once or twice daily
    children 6 to under 12 years of age
    • chew 1 chocolated piece once or twice daily
    children under 6 years of age
    • ask a doctor

  • Other Information

    • ​each piece contains: ​potassium 5 mg
    • contains milk and soy ingredients
    • gluten free
    • store at 15o- 25oC (59o- 77oF)
  • Inactive Ingredients

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

  • Questions or comments? 248-449-9300

  • PRINCIPAL DISPLAY PANEL - 15 mg CHEWABLE TABLET CARTON

    ​QC®

    Quality Choice

    NDC 63868-266-24

    Regular Strength

    Chocolated Laxative

    Relieves Occasional Constipation

    Sennosides, USP, 15 mg | Stimulant Laxative

    • Relief of Occasional Constipation
    • Chocolate Flavored

    *Compare to active ingredient in ex-lax®

    Satisfaction Guaranteed

    24 pieces

    Made in the USA

    Distributed by C.D.M.A., Inc.

    43157 W. Nine Mile

    Novi, MI 48376-0995

    www.qualitychoice.com

    Questions: 248-449-9300

    image description

  • INGREDIENTS AND APPEARANCE
    CHOCOLATED LAXATIVE 
    sennosides stimulant laxative tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-266
    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)  
    cotton seed (UNII: DI0ZRJ0MXN)  
    palm kernel oil (UNII: B0S90M0233)  
    sodium chloride (UNII: 451W47IQ8X)  
    lecithin, soybean (UNII: 1DI56QDM62)  
    sucrose (UNII: C151H8M554)  
    vanilla (UNII: Q74T35078H)  
    whey (UNII: 8617Z5FMF6)  
    Product Characteristics
    Colorbrown (brown) Scoreno score
    ShapeRECTANGLE (RECTANGLE) Size9mm
    FlavorCHOCOLATEImprint Code CL
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-266-242 in 1 CARTON01/01/2014
    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 finalpart33401/01/2014
    Labeler - C.D.M.A., Inc. (011920774)
    Registrant - Aphena Pharma Solutions MD, LLC (829739833)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aphena Pharma Solutions MD, LLC829739833MANUFACTURE(63868-266)
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