Label: MAXIMUM STRENGTH LAXATIVE- sennosides tablet, coated

  • 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 22, 2023

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  • DRUG FACTS

  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)

    Sennosides USP, 25 mg

  • PURPOSE

    Purpose

    Stimulant Laxative

  • INDICATIONS & USAGE

    Uses

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

    Warnings

  • DO NOT USE

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

  • ASK 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 DOCTOR/PHARMACIST

    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

    When using this product

    • do not use for a period longer than 1 week
  • STOP USE

    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.
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Directions

    • Swallow tablets(s) with a glass of water.
    • Swallow tablets(s) whole, do not crush, break, or chew.

    adults and children 12 years of age and older: take 2 tablets once or twice daily

    children 6 to under 12 years of age: take 1 tablet once or twice daily

    children under 6 years of age: ask a doctor

  • OTHER SAFETY INFORMATION

    Other information

    • each tablet contains: calcium 40 mg, sodium 2 mg (VERY LOW SODIUM)
    • store between 20°-25°C (68°-77°F)
  • INACTIVE INGREDIENT

    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, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, shellac, stearic acid, sugar, talc, titanium dioxide.

  • QUESTIONS

    Questions or comments?

    call 1-877-290-4008

  • PRINCIPAL DISPLAY PANEL

    195R-riteaid-24s-ifc195R-Rite-aid-maximumstrengthlaxative-carton-label-30s

  • INGREDIENTS AND APPEARANCE
    MAXIMUM STRENGTH LAXATIVE 
    sennosides tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-7896
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES25 mg
    Inactive Ingredients
    Ingredient NameStrength
    ACACIA (UNII: 5C5403N26O)  
    CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    KAOLIN (UNII: 24H4NWX5CO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    POVIDONE (UNII: FZ989GH94E)  
    SHELLAC (UNII: 46N107B71O)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    RAW SUGAR (UNII: 8M707QY5GH)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorblueScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-7896-496 in 1 CARTON; Type 0: Not a Combination Product12/31/2021
    2NDC:11822-7896-02 in 1 CARTON09/01/2020
    212 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33409/01/2020
    Labeler - RITE AID (014578892)
    Registrant - TIME CAP LABORATORIES, INC. (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    TIME CAP LABORATORIES, INC.037052099manufacture(11822-7896)
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