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 November 16, 2020

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  • Drug Facts

    Active ingredient (in each 15 mL Tablespoon)

    Magnesium hydroxide USP 1200 mg

  • Purpose

    Saline laxative

  • Use

    relieves occasional constipation (irregularity). This product usually produces bowel movement in ½ 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 (1-800-222-1222) right away.

  • Directions

    • do not exceed the maximum recommended daily dose in a 24 hour period
    • shake well before use
    • 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.
    • for accurate dosing, only use the dosing cup provided
    • do not use any other dosing device
    • TBSP = Tablespoon, mL = milliliter
    age
    		dose
    adults and children 12 years and older
    		30 mL (2 TBSP) to 60 mL (4 TBSP)
    children 6 to 11 years
    		15 mL (1 TBSP) to 30 mL (2 TBSP)
    children under 6 years
    		ask a doctor
  • Other information

    • each tablespoon (15 mL) contains : calcium 20 mg and magnesium 535 mg
    • store at 20-25°C (68-77°F). Avoid excessive heat above 40°C (104°F) and avoid freezing. Close cap tightly after use.
  • Inactive ingredients

    purified water

    Questions or comments?
    1-855-274-4122
    * This product is not manufactured or distributed by Bayer Healthcare LLC, distributor of Phillips’® Milk of Magnesia.

    Distributed by:
    Aurohealth LLC.
    2572 Brunswick Pike
    Lawrenceville, NJ 08648

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 12 FL OZ (355 mL) Bottle

    AUROHEALTH
    NDC 58602-322-16
    *Compare to the active ingredient in Phillips’® Milk of Magnesia
    Milk of Magnesia
    Saline Laxative
    Each 15 mL(1TBSP) dose of oral solution contains: 1200 mg - Magnesium hydroxide USP

    • Stimulant Free
    • Comfortable, Cramp Free Relief
    • Sugar Free

    TAMPER-EVIDENT: Do not use if imprinted neckband is missing or broken.
    12 FL OZ
    (355 mL)
    Original Flavor
    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 12 FL OZ (355 mL) Bottle

  • INGREDIENTS AND APPEARANCE
    MILK OF MAGNESIA 
    magnesium hydroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-322
    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)  
    Product Characteristics
    ColorWHITE (White to off-white) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58602-322-16355 mL in 1 BOTTLE; Type 0: Not a Combination Product01/28/201609/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart33401/28/201609/01/2022
    Labeler - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurohealth LLC078728447MANUFACTURE(58602-322)
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