MAGMEX (MAGNESIUM HYDROXIDE) LIQUID [MENPER DISTRIBUTORS, INC.]

MAGMEX (MAGNESIUM HYDROXIDE) LIQUID [MENPER DISTRIBUTORS, INC.]
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NDC 53145-060-04
Set ID f9fb93da-67e8-4745-a8b3-bebfe6fdda5c
Category HUMAN OTC DRUG LABEL
Packager Menper Distributors, Inc.
Generic Name
Product Class
Product Number
Application Number PART334
  • ACTIVE INGREDIENT

    Active ingredient (in each 15 mL TBSP)

    Magnesium hydroxide 1200 mg

  • PURPOSE

    Purpose

    Saline laxative

  • INDICATIONS & USAGE

    Uses

    •relieves occasional constipation (irregularity)

    •generally produces bowel movement in ½ to 6 hours

  • WARNINGS

    Warnings

  • ASK DOCTOR

    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 more than 2 weeks

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are

    taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

  • 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. (1-800-222-1222)

  • DOSAGE & ADMINISTRATION

    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, use dose cup provided

    •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 SAFETY INFORMATION

    Other information

    •each tablespoon (15 mL) contains: calcium 20 mg, magnesium 595 mg, and sodium 2 mg

    •does not meet USP requirements for preservative effectiveness

    •store at 20-25oC (68-77oF)

    •keep tightly closed

    •avoid freezing

  • INACTIVE INGREDIENT

    Inactive ingredients

    light mineral oil, peppermint oil, purified water, saccharin sodium

  • QUESTIONS

    Questions? 1-800-560-5223 Monday-Friday 9 AM - 4 PM EST

  • PRINCIPAL DISPLAY PANEL

    Magmex Label

  • INGREDIENTS AND APPEARANCE
    MAGMEX 
    magnesium hydroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53145-060
    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
    MINERAL OIL (UNII: T5L8T28FGP)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    SODIUM HYPOCHLORITE (UNII: DY38VHM5OD)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SPEARMINT (UNII: J7I2T6IV1N)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53145-060-041 in 1 CARTON
    1133 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33402/21/2012
    Labeler - Menper Distributors, Inc. (101947166)

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