Label: PHILLIPS MILK OF MAGNESIA CONCENTRATED FRESH STRAWBERRY liquid

  • NDC Code(s): 0280-0033-08, 0280-0033-09
  • 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 June 13, 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 2400 mgSaline laxative

  • PURPOSE

    Saline laxative

  • Use

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

  • WARNINGS

    Warnings

  • DO NOT USE

    Do not use if you have ever had an allergic reaction to this product or any of its ingredients

  • 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 DOCTOR/PHARMACIST

    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
  • 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 glas (8 oz) of liquid with each dose.
    • for accurate dosing, only use the dosing cup provided
    • mL = milliliter
    • Adults and children 12 years and older: 15 mL to 30 mL
    • Children under 12 years: ask a doctor
  • Other information

    • each 15 mL contains: magnesium 1000 mg
    • store at room temperature. Avoid freezing. Close cap tightly after use.
  • Inactive ingredients

    anhydrous citric acid, D&C red #28, flavors, glycerin, propylene glycol, purified water, sodium hypochlorite, sorbitol, sucrose

  • QUESTIONS

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

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    PHILLIPS MILK OF MAGNESIA CONCENTRATED  FRESH STRAWBERRY
    phillips milk of magnesia concentrated fresh strawberry liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-0033
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM HYDROXIDE2400 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM HYPOCHLORITE (UNII: DY38VHM5OD)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    SUCROSE (UNII: C151H8M554)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorSTRAWBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0280-0033-081 in 1 CARTON12/18/2014
    1237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:0280-0033-09237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/20/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33412/18/2014
    Labeler - Bayer HealthCare LLC. (112117283)