Label: LEADER SALINE LAXATIVE - CHERRY- magnesium citrate liquid

  • 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 27, 2023

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  • Active ingredients ( in each fl. oz.)

    Magnesium Citrate 1.745 g

  • Purpose

    Saline Laxative

  • Uses

    • for relief of occasional constipation (irregularity)
    • generally produces bowel movement in 1/2 to 6 hours
  • Warnings

    Ask a docotor before use if you have

    • kidney disease
    • a magnesium restricted diet
    • a potassium restricted diet
    • stomach pain, nausea, or vomiting
    • noticed a sudden change in bowel habits that persists over a period of 2 weeks
    • already used a laxative for a period longer than 1 week

    Ask a doctor or pharmacist before use if you are

    • taking any other drug.
    • Take this product 2 or more hours before or after other drugs. Laxatives may affect how other drug work.

    Stop using and ask a doctor if

    you have rectal bleeding or failure to have a bowel movement after use. These could 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 (1-800-222-1222) right away.

  • Directions

    • shake well before use
    • drink a full glass (8 ounces) of liquid with each dose
    • may be taken as a single daily dose or divided doses
    adults and children 12 years of age and over6.5 to 10 fl. oz., maximum 10 fl. oz. in 24 hours
    children 6 to 12 years of age3 to 7 fl. oz., maximum 7 fl. oz. in 24 hours
    children 2 to under 6 years of age2 to 3 fl. oz., maximum 3 fl. oz. in 24 hours
    children under 2 years of ageask a doctor

  • Other information

    • each fl. oz. contains: magnesium 290 mg
    • each fl. oz. contains: sodium 3 mg
    • each fl. oz. contains: potassium 5 mg
  • Inactive ingredients

    benzoic acid, citric acid, disodium EDTA, flavor, potassium sorbate, purified water, sucralose

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL

  • INGREDIENTS AND APPEARANCE
    LEADER  SALINE LAXATIVE - CHERRY
    magnesium citrate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0619
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAGNESIUM CITRATE (UNII: RHO26O1T9V) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM CITRATE1.745 g  in 29.6 mL
    Inactive Ingredients
    Ingredient NameStrength
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    WATER (UNII: 059QF0KO0R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorLEMONImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0619-1296 mL in 1 BOTTLE; Type 0: Not a Combination Product02/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33402/01/2023
    Labeler - CARDINAL HEALTH (063997360)
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