Label: MAGNESIUM CITRATE solution

  • 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 September 19, 2022

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  • Active ingredient

    Active ingredient (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 doctor before use if you have

    • kidney disease
    • a magnesium restricted diet
    • abdominal 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 durgs work.

  • Stop use 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 right away.

    Store at temperature between 46° and 86°F (8° abd 30°C)

  • Directions

    • shake well before using
    • drink a full glass (8 ounces) of liquid with each dose
    • may be taken as a single daily dose or in divide doses

    adults and children 12 years of age and over - 6.5 to 10 fl oz in 24 hours

    children 6 to under 12 years of age - 3 to 7 fl oz maximum 7 fl oz in 24 hours

    children 2 to under 6 years of age - 2 to 3 fl oz maximum 3 fl oz in 24 hours

    children under 2 years of age - ask a doctor

  • Other information

    • each fl oz contains: magnesium 290 mg
    • each fl oz contains: sodium 1 mg
  • inactive ingredients

    benzoic acid, citric acid, disodium EDTA, flavor, sucralose, water

  • Questions

    Call 1-88-593-0593

  • Adverse reaction

    MADE WITH PRIDE & CARE FOR H-E-B

    SAN ANTONIO, TN 78204

  • Principal Panel Display

    H-E-B

    Magnesium Citrate

    Oral solution

    saline Laxative

    • Relief of: Occasion Constipation

    Sugar & dye free

    Gluten Free

    Lemon Flavor

    10 FL OZ (296 mL)

    Do Not Use If Tamper Evident Twist-off Cap Is Missing, Broken or Separated From Neckring

    image description

  • INGREDIENTS AND APPEARANCE
    MAGNESIUM CITRATE 
    magnesium citrate solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-769
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAGNESIUM CITRATE (UNII: RHO26O1T9V) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM CITRATE0.059 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37808-769-38296 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/07/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33409/07/2021
    Labeler - H E Butt (007924756)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(37808-769)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(37808-769)
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