Label: LAXATIVE PILLS MAXIMUM STRENGTH- sennosides tablet 

  • Label RSS
  • NDC Code(s): 41520-142-24
  • Packager: Care One (American Sales Company)
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 12/12

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

  • Active ingredient (in each tablet)

    Sennosides USP, 25 mg

    Close
  • Purpose

    Stimulant laxative

    Close
  • Uses

    •  relief of occasional constipation (irregularity). This product generally produces bowel movement within 6 to 12 hours.
    Close
  • Warnings

    Do not use

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

    Ask a doctor before use if

    •  you notice a sudden change in bowel habits that persists over a period of 2 weeks

    Stop use and ask a doctor if

    •  you have rectal bleeding
    •  you fail to have a bowel movement after use. These may be signs of a serious condition.

    If pregnant or breast-feeding,

     ask a health care professional before use.

    Keep out of reach of children

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

    Close
  • Directions

      adults and children 12 years of age and older  take 2 tablets once or twice daily with a glass of water
      children 6 to under 12 years of age   take 1 tablet once or twice daily with a glass of water
      children under 6 years of age consult a doctor
    Close
  • Other information

    • each tablet contains: calcium 40 mg/ tablet
    • each tablet contains: magnesium 10 mg/ tablet
    • each tablet contains: sodium 3 mg/ tablet VERY LOW SODIUM 
    • store at 15º - 30º C (59º-86º F)
    • keep in a dry place
    • do not expose to excessive heat
    • *This product is not manufactured or distributed by Novartis Consumer Health Inc., owner of the registered trademark Ex-Lax®
    Close
  • Inactive ingredients

    acacia, calcium sulfate anhydrous, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C Blue #1 Aluminum Lake, iron oxide, iron oxide Black, iron oxide Yellow, kaolin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, shellac, sodium lauryl sulfate, stearic acid, sugar, talc, and titanium dioxide. May also contain:  anhydrous lactose, isopropyl alcohol, Lake Brilliant Blue FCF, malto dextrin, Opacode Black S-1-17823, Opagloss 6000P, tartaric acid

    Close
  • Principal Display Panel

    Compare to the active ingredient in maximum strength EX-LAX® *

    Laxative Pills

    Maximum Strength

    for gentle, dependable overnight relief

    25 mg Sennosides**

    **Natural senna ingredient

    TAMPER EVIDENT- USE ONLY IF BLISTERS ARE INTACT

    Distributed by: American Sales Company

    4201 walden avenue, Lancaster, NY 14086

    www.care1.com

    Close
  • Product Label

    CareOne

    sennosides 25 mg

    Close
  • INGREDIENTS AND APPEARANCE
    LAXATIVE PILLS  MAXIMUM STRENGTH
    sennosides tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:41520-142
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SENNOSIDES (SENNOSIDES) SENNOSIDES 25 mg
    Inactive Ingredients
    Ingredient Name Strength
    ACACIA  
    CALCIUM SULFATE ANHYDROUS  
    CARNAUBA WAX  
    SILICON DIOXIDE  
    STARCH, CORN  
    CROSCARMELLOSE SODIUM  
    CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE  
    FD&C BLUE NO. 1  
    FERRIC OXIDE RED  
    FERROSOFERRIC OXIDE  
    FERRIC OXIDE YELLOW  
    KAOLIN  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    POLYETHYLENE GLYCOLS  
    POVIDONES  
    STARCH, CORN  
    SHELLAC  
    SODIUM LAURYL SULFATE  
    STEARIC ACID  
    SUCROSE  
    TALC  
    TITANIUM DIOXIDE  
    ANHYDROUS LACTOSE  
    ISOPROPYL ALCOHOL  
    MALTODEXTRIN  
    TARTARIC ACID  
    Product Characteristics
    Color BLUE Score no score
    Shape ROUND Size 10mm
    Flavor Imprint Code TCL083;S25
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:41520-142-24 2 in 1 CARTON
    1 12 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part334 08/05/2010
    Labeler - Care One (American Sales Company) (809183973)
    Registrant - P and L Development of New York Corporation (800014821)
    Close