Label: MILK OF MAGNESIA MINT- magnesium hydroxide liquid

  • NDC Code(s): 62011-0123-1
  • Packager: STRATEGIC SOURCING SERVICES LLC
  • Category: HUMAN OTC DRUG LABEL

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 December 26, 2019

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  • Active ingredient (1 Tablespoon)

    Magnesium hydroxide 1200 mg

  • Purpose

    Saline laxative

  • Uses

    • relieves 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
    • stomach pain, nausea, or vomiting
    • a sudden change in bowel habits that lasts more than 14 days

    Ask a doctor or pharmacist before use if you are presently taking a prescription drug.

    This product may interact with certain prescription drugs.

    Stop use and ask a doctor if

    • you have rectal bleeding or failure to have a bowel movement after using this product. These could be signs of a serious condition.
    • you need to use a laxative for more than 1 week

    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) immediately.

  • Directions

    • shake well before use
    • do not exceed the maximum recommended daily dose in a 24 hour period
    • dose may be taken once a day preferably at bedtime, in divided doses, or as directed by a doctor
    • drink a full glass (8 oz) of liquid with each dose
    adults and children 12 years and over2 to 4 tablespoonfuls (TBSP)

    children 6 to 11 years

    1 to 2 tablespoonfuls (TBSP)

    children under 6 years

    ask a doctor

  • Other information

    each tablespoon contains: magnesium 500 mg

    • do not freeze

    • store at room temperature tightly closed

  • Inactive ingredients

    flavor, purified water, saccharin sodium, sodium hypochlorite

  • package Label

    1

  • INGREDIENTS AND APPEARANCE
    MILK OF MAGNESIA MINT 
    magnesium hydroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62011-0123
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE1200 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYPOCHLORITE (UNII: DY38VHM5OD)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINT (mint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62011-0123-1355 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33404/01/2012
    Labeler - STRATEGIC SOURCING SERVICES LLC (116956644)
    Registrant - GCP Laboratories (965480861)
    Establishment
    NameAddressID/FEIBusiness Operations
    GCP Laboratories965480861manufacture(62011-0123)