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 October 1, 2014

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  • Active Ingredient (in each 5 mL Tablespoon)

    Magnesium Hydroxide 400 mg

  • Purpose

    Saline laxative

  • Use

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

    Ask a doctor before use if you have

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

    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 one 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
    •
    mL = milliliter, TBSP = Tablespoonful

    adults and children 12 years and older

    2 to 4 Tbsp.

    children 6 to 11 years

    1 to 2 Tbsp.

    children under 6 years

    ask 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 tablespoon (5 mL) contains: sodium 4 mg
    •
    each tablespoon (5 mL) contains: magnesium 166 mg
  • Inactive ingredients

    carboxymethylcellulose sodium, citric acid, D&C red #28, flavor, glycerin, microcrystalline cellulose, water, sodium citrate, sodium hypochlorite, sucrose, xanthan gum.

  • 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:61715-131
    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
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SODIUM HYPOCHLORITE (UNII: DY38VHM5OD)  
    SUCROSE (UNII: C151H8M554)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorPINK (PINK) Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61715-131-04355 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33410/01/2014
    Labeler - Kinray LLC (012574513)
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