Label: MILK OF MAGNESIA- magnesium hydroxide 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 April 30, 2018

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  • Active Ingredient (in each 5 mL) One teaspoonful)

    Magnesium Hydroxide 400 mg

  • Purpose

    Saline laxative/Antacid

  • Use

    Laxative

    •
    relieves occasional constipation (irregularity).
    •
    generally produces bowel movement in ½ to 6 hours.

    Antacid

    •
    relieves acid indigestion, sour stomach, heartburn.
  • Warnings

    Ask a doctor before use if you have

    •
    kidney disease
    •
    stomach pain, nausea or vomiting
    •
    notice a sudden change in bowel habits that persists over a period of 2 weeks
    •
    a magnesium-restricted diet

    Ask a doctor or pharmacist before use if you are

    taking a prescription drug. Antacid may interact with certain prescription drugs.

    When using this product

    •
    it may have a laxative effect
    •
    do not exceed the maximum recommended daily dosgae in a 24-hour period

    Stop use and ask a doctor if

    Laxative

    •
    you have rectal bleeding or failure to have a bowel movement after use. These may indicate a serious condition.
    •
    you need to use a laxative for more than one week

    Antacid

    •
    symptoms last for more than 2 weeks.

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    In case of accidental overdose, get medical help or contact a Poison Control Center immediately.

  • Directions

    •
    shake well before use
    Laxative use:Antacid use

    Do not use dosage cup for ages under 12 years.

    Follow each dose with a full glass (8 oz) of liquid.

    Do not use dosage cup.

    Follow each dose with a little water.
    adults and children 12 years and older2-4 TBSP (30-60 mL) once a day1-3 tsp (5-15 mL) up to 4 times a day
    6 to 11 years1-2 TBSP (15-30 mL) once a dayask a doctor
    2 to 5 years1-3 tsp (5-15 mL) once a dayask a doctor
    under 2 yearsask a doctorask a doctor
  • Other information

    •
    TAMPER EVIDENT: Do not use if breakaway band on cap is broken or missing.
    •
    Store at room temperature 15º - 30ºC (59º - 86ºF)
    •
    keep tightly closed
    •
    keep from freezing
    •
    each teaspoon (5 mL) contains: magnesium 166 mg
    •
    each teaspoon (5 mL) contains: sodium 1 mg
  • Inactive ingredients

    citric acid, flavor, purified water, sodium hypochlorite.

  • Principal Display Panel

    Milk of Magnesia Label

  • INGREDIENTS AND APPEARANCE
    MILK OF MAGNESIA 
    magnesium hydroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53807-401
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE400 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYPOCHLORITE (UNII: DY38VHM5OD)  
    Product Characteristics
    ColorWHITE (opaque) Score    
    ShapeSize
    FlavorPEPPERMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53807-401-12355 mL in 1 BOTTLE; Type 0: Not a Combination Product03/16/1999
    2NDC:53807-401-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product03/16/1999
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33403/16/1999
    Labeler - Rij Pharmaceutical Corporation (144679156)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rij Pharmaceutical Corporation144679156manufacture(53807-401)
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