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
  • 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 March 17, 2022

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

  • 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 finalpart33101/31/2019
    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)