Label: MILK OF MAGNESIA- magnesium hydroxide liquid

  • NDC Code(s): 36800-649-12
  • Packager: TOP CARE (TOPCO ASSOCIATES LLC)
  • 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 8, 2021

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  • Active ingredient (in each 15 mL)

    Magnesium hydroxide 1200 mg

  • Purpose

    Saline laxative

  • Uses

    • relieves occasional constipation (irregularity)
    • usually 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 over 14 days

    Ask a doctor or pharmacist before use if you are taking a prescription drug. This product may interact with certain prescription drugs.

    Stop use and ask a doctor if

    • you have rectal bleeding or no 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 right away.

  • 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
    agedose
    adults and children 12 years and over30 mL to 60 mL
    children 6 to 11 years15 mL to 30 mL
    children under 6 yearsask a doctor

  • Other information

    • each 15 mL tablespoonful contains: magnesium 500 mg
    • avoid freezing
    • store at room temperature tightly closed
  • Inactive ingredients

    purified water, sodium hypochlorite

    Questions or Comments?

    1-800-540-3765

  • package label

    1

  • INGREDIENTS AND APPEARANCE
    MILK OF MAGNESIA 
    magnesium hydroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-649
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-649-12355 mL in 1 BOTTLE; Type 0: Not a Combination Product12/18/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33412/01/2020
    Labeler - TOP CARE (TOPCO ASSOCIATES LLC) (006935977)
    Registrant - GCP Laboratories (965480861)
    Establishment
    NameAddressID/FEIBusiness Operations
    GCP Laboratories965480861manufacture(36800-649)
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