Label: LAXATIVE REGULAR STRENGTH, CHOCOLATED STIMULANT LAXATIVE SENNOSIDES, EQUALINE- sennosides 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 10, 2023

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  • Active ingredient (in each piece of 9 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 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 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 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?

    1-877-932-7948

  • Principal Display Panel - 15 mg Carton Label

    NDC 41163-625-18

    compare to
    ex-lax    ®
    active ingredient*

    EQUALINE*

    regular strength
    chocolated stimulant
    laxative

    sennosides, USP, 15 mg

    for gentle, dependable
    overnight relief

    18 pieces

    chocolate flavored

    Principal Display Panel - 15 mg Carton Label
  • INGREDIENTS AND APPEARANCE
    LAXATIVE   REGULAR STRENGTH, CHOCOLATED STIMULANT LAXATIVE SENNOSIDES, EQUALINE
    sennosides tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-625
    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
    FlavorImprint Code CL
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41163-625-182 in 1 CARTON02/24/2021
    19 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33402/24/2021
    Labeler - Supervalu Inc. (006961411)
    Registrant - Aphena Pharma Solutions MD, LLC (829739833)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aphena Pharma Solutions MD, LLC829739833MANUFACTURE(41163-625)
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