Label: HUMCO MILK OF MAGNESIA- magnesium hydroxide suspension

  • NDC Code(s): 0395-1672-16
  • Packager: Humco Holding Group, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 15, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Magnesium Hydroxide 400 mg per teaspoon (5 mL)

  • Purpose

    Antacid/Saline Laxative

  • Use

    As an antacid: helps relieve acid ingestion, heartburn and sour stomach.

    As a laxative: For the temporary relief of occasional constipation. Bowel movement is generally produced in 1.2 to 6 hours.

  • WARNINGS Ask a doctor before use if you have.

    Abdominal pain, nausea, vomiting, kidney desease, are on a magnesium restricted diet, a sudden change in bowel habits lasting longer than 14 days, if you are taking prescription drugs. Antacids may interact with certain prescription drugs.

  • Stop use and ask a doctor.

    If you have rectal bleeding or have no bowel movement after using this product. this could be signs of a serious codition, if you need to use a laxative for more than one week. Frequent or prolonged use may result in the dependence on laxatives.

  • When using this product.

    As an antacid, do not take more than the maximum recomended daily dose in a 24 hr. period or take the maximum dose for more than two weeks, except under the advise of a doctor. May have laxative effect.

    If pregnant or breastfeeding ask a health professional before use.

  • Keep out of reach of children.

    In the case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

  • Directions (Shake well before use) 

    As an antacid: Adults and children 12 yrs. of age and older: 1 to 3 teaspoonfuls with a little water, or as directed by a doctor.

    As a laxative: Adults and children 12 yrs. of age and older: 1 to 4 tablespoonfuls followed by a full 8 oz. glass of water.

    Children 6 thru 11 yr. of age: 1 to 2 tablespoonfuls followed by a full 8 oz. glass of water.

    children 2 thru 5 yrs. of age: 1 to 3 teaspoonfuls followed by a full 8 oz. glass of water.

    Children under 2 yrs. of age: consult a doctor before use.

  • Other information

    acid neutralizing capacilty: 10.0 mEq per teaspoon.

    keep tightly closed and avoid freezing.

  • Inactive ingredient.

    Purified water

  • Principal display panel

    Milk of Mag.jpg

  • INGREDIENTS AND APPEARANCE
    HUMCO MILK OF MAGNESIA 
    magnesium hydroxide suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0395-1672
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM HYDROXIDE80 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0395-1672-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/31/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00101/31/2019
    Labeler - Humco Holding Group, Inc. (825672884)
    Registrant - Pharma Nobis, LLC (118564114)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Nobis, LLC118564114manufacture(0395-1672) , analysis(0395-1672) , pack(0395-1672) , label(0395-1672)
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