Label: PHILLIPS ORIGINAL MILK OF MAGNESIA liquid

  • NDC Code(s): 0280-0030-04, 0280-0030-12, 0280-0030-26
  • Packager: Bayer HealthCare 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 August 22, 2017

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each 15 mL) Purpose

    Magnesium hydroxide 1200 mg...............…………..........Saline laxative

  • PURPOSE

    Saline laxative

  • Use

    Use relieves occasional constipation (irregularity). This product usually produces bowel movement in ½ to 6 hours.

  • WARNINGS

    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

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

  • STOP USE

    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

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center 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

    ● mL = milliliter

    adults and children 12 years and older30 mL to 60 mL
    children 6 to 11 years15 mL to 30 mL
    children under 6 yearsask a doctor

  • OTHER SAFETY INFORMATION

    Other information

    each tablespoon (15 mL) contains: magnesium 500 mg

    ● store at room temperature. Avoid excessive heat above 40°C (104°F). Avoid freezing. Close cap tightly after use.

  • INACTIVE INGREDIENT

    Inactive ingredients purified water, sodium hypochlorite

  • QUESTIONS

    Questions or comments? 1-800-986-0369 (Mon – Fri 9AM – 5PM EST)

  • PRINCIPAL DISPLAY PANEL

    original frontoriginal back

  • INGREDIENTS AND APPEARANCE
    PHILLIPS ORIGINAL MILK OF MAGNESIA 
    phillips original milk of magnesia liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-0030
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM HYDROXIDE1200 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYPOCHLORITE (UNII: DY38VHM5OD)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0280-0030-12355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/16/2014
    2NDC:0280-0030-26769 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/16/2014
    3NDC:0280-0030-041 in 1 CARTON12/16/2014
    3118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33412/16/2014
    Labeler - Bayer HealthCare LLC. (112117283)