Label: CAREONE MILK OF MAGNESIA ORIGINAL MILK OF MAGNESIA ORIGINAL- magnesium hydroxide liquid

  • NDC Code(s): 72476-661-05
  • Packager: Retail Business Services, 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 April 27, 2022

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  • ACTIVE INGREDIENT(S)

    Magnesium hydroxide 1200 mg

  • PURPOSE

    Saline laxative

  • USE(S)

    relieves occasional constipation (irregularity). This product usually produces bowel movement in 1/2 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 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 PREGNANCY 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.
    • for accurate dosing, only use the dosing cup provided
    • mL=milliliter

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

                                 

  • OTHER INFORMATION

    • each 15 mL contains: magnesium 500 mg
    • store at 20  -  25oC (68 - 77oF), Avoid excessive heat above 40oC(104oF). Avoid freezing. Close cap tightly after use.
  • INACTIVE INGREDIENTS

    citric acid, glycerin, hydroxyethyl cellulose, purified water, sodium hypochlorite, sucrose.

  • PRINCIPAL DISPLAY PANEL

    CAREone TM

    NDC : 72476-661-05

    Compare to the active ingredients in Phillips'® Milk of Magnesia*

    MILK OF MAGNESIA

    Saline Laxative

    Magnesium Hydroxide 1200 mg per 15 mL

    Original Flavor

    Comfortable, Cramp Free Relief!

    Stimulant Free

    12FL OZ (355 mL)


    701-05


     


  • INGREDIENTS AND APPEARANCE
    CAREONE MILK OF MAGNESIA ORIGINAL  MILK OF MAGNESIA ORIGINAL
    magnesium hydroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72476-661
    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
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    Glycerin (UNII: PDC6A3C0OX)  
    HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16)  
    water (UNII: 059QF0KO0R)  
    Sodium Hypochlorite (UNII: DY38VHM5OD)  
    Sucrose (UNII: C151H8M554)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72476-661-05355 mL in 1 BOTTLE; Type 0: Not a Combination Product04/27/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart33404/27/2022
    Labeler - Retail Business Services, LLC. (967989935)
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