Label: MILK OF MAGNESIA- magnesium hydroxide suspension

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 January 24, 2018

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

  • SPL UNCLASSIFIED SECTION

    saline laxative/antacid

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  • DESCRIPTION

    Active Ingredient

    (in each 5 mL = 1 teaspoonful)

    Magnesium Hydroxide.................400 mg

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  • Inactive Ingredients

    anhydrous citric acid, benzyl alcohol, methylparaben, propylene glycol, propylparaben, purified water.

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  • FOR USE AS A LAXATIVE

    INDICATIONS

    Uses

    • For relief of occasional constipation (irregularity)
    • This product generally 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 more than 2 weeks

    Ask a doctor or pharmacist before use if you are

    • presently 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

    • shake well before use
    • drink a full glass (8 oz) of liquid with each dose
    • mL = milliliter

    Adults and children

    12 years of age and older

    30 mL to 60 mL

    Children

    6 to 11 years of age

    15 mL to 30 mL

    Children

    under 6 years of age

    Consult a

    physician.

    or as directed by a physician.

    • The dose may be taken as a single daily dose or in divided doses.

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  • FOR USE AS AN ANTACID

    INDICATIONS

    Uses

    For the relief of

    • heartburn
    • sour stomach
    • acid indigestion
    • and upset stomach associated with these symptoms

    WARNINGS

    Do not take more than 12 teaspoonfuls in a 24-hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a physician

    May have laxative effect

    Ask a doctor before use if you have

    • kidney disease
    • a magnesium-restricted diet

    Ask a doctor or pharmacist before use if you are

    • presently taking a prescription drug. Antacids may interact with certain prescription drugs.

    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

    • shake well before use
    • mL = milliliter
    • adults and children 12 years old and older, take 1 to 3 teaspoonfuls (5 to 15 mL) four times a day or as directed by a physician
    • do not take more than 12 teaspoonfuls (60 mL) in 24-hour period
    • do not use the maximum dosage for more than 2 weeks
    • children under 12 years: consult a physician
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  • 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 (1-800-222-1222) right away.

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  • HOW SUPPLIED

    Milk of Magnesia USP 400 mg/5 mL is a white opaque liquid supplied as follows:

    NDC 66689-053-01: 30 mL unit-dose cup

    NCD 66689-053-99: Case contains 100 unit-dose cups of 30 mL (NDC 66689-053-01), packaged in 10 trays of 10 unit-dose cups each.

    STORAGE

    Other Information

    • Protect from freezing
    • Store at 20° to 25°C (68° to 77°F)

    Questions or Comments?

    Call 1-888-655-1505 (toll-free)

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  • SPL UNCLASSIFIED SECTION

    Distributed by:

    VistaPharm, Inc.

    Largo, FL 33771, USA

    VP2152R1

    09/17

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  • PRINCIPAL DISPLAY PANEL - 30 mL Cup Label

    MILK OF MAGNESIA,  USP

    2400 mg of Magnesium Hydroxide per 30 mL

    Shake Well Before Administration

    Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F).

    Delivers 30 mL
    Magnesium Hydroxide 2400 mg.

    Manufactured by:
    VistaPharm, Inc.
    Largo, FL 33771, USA

    VP2153R1

    07/17

    PRINCIPAL DISPLAY PANEL - 30 mL Cup Label
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  • INGREDIENTS AND APPEARANCE
    MILK OF MAGNESIA 
    magnesium hydroxide suspension
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:66689-053
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE 400 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    HYPROMELLOSE 2910 (4000 MPA.S) (UNII: RN3152OP35)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 4 (UNII: CZ227117JE)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SORBITOL (UNII: 506T60A25R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Product Characteristics
    Color WHITE Score     
    Shape Size
    Flavor SPEARMINT Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:66689-053-99 10 in 1 CASE 04/19/2018
    1 10 in 1 TRAY
    1 30 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part331 04/19/2018
    Labeler - VistaPharm, Inc. (116743084)
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