Label: MAGNESIUM CITRATE SALINE LAXATIVE- 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 18, 2023

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  • Active ingredient (30ml (approx. 1 Fl. oz))

    Magnesium citrate 1.745g

  • Purpose

    Saline laxative

  • Uses

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

    Do not use

     laxative products for longer than 1 week unless directed by a doctor.

    Ask a doctor before use if you have

    • kidney disease
    • a magnesium restricted diet
    • a sodium restricted diet
    • stomach pain, nausea or vomiting
    • noticed a sudden change in bowel habits that lasts more than 1 week

    Ask a doctor or pharmacist before use if you

    are presently taking a prescription drug.

    When using this product

    do not exceed the maximum recommended daily dosage in a 24 hour period.

    Stop use and ask a doctor if

    you have rectal bleeding or no 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

    • drink a full glass (8 ounces) of liquid with each dose.
    • may be taken as a single daily dose or in divided doses.
     adults and children 12 years of age and over 1/2 bottle to 1 bottle (10 fl oz)
     children 6 to 11 years of age 1/3 bottle to 1/2 bottle
     children under 6 years of age consult a doctor

  • Other information

    • each fliud ounce contains: magnesium 280 mg, sodium 6.7 mg
    • store between 46º-86ºF (8º-30ºC). Do not refrigerate.
    • protect from excessive heat and freezing
    • discard unused product within 24 hours of opening bottle
  • Inactive ingredients

    Purified water, citric acid, lemon flavor, sodium benzoate, saccharin sodium, sorbic acid, disodium edetate

  • Questions or comments?

    Call  toll-free 1-877-225-6999

    Manufactured for:

    Akron Pharma Inc.,

    Fairfield, NJ-07004 

    www.akronpharma.com

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    MAGNESIUM CITRATE  SALINE LAXATIVE
    magnesium citrate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71399-7889
    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
    WATER (UNII: 059QF0KO0R)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBIC ACID (UNII: X045WJ989B)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorLEMONImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71399-7889-1296 mL in 1 BOTTLE; Type 0: Not a Combination Product01/02/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33401/02/2023
    Labeler - AKRON PHARMA INC (067878881)
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