Label: MILK OF MAGNESIA concentrate

  • NDC Code(s): 0054-3567-49, 0054-3567-61
  • Packager: West-Ward Pharmaceuticals Corp.
  • Category: HUMAN OTC DRUG LABEL

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 May 8, 2015

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • CONCENTRATED Milk of Magnesia (Lemon Flavored)

  • Drug Facts

    Serving Size: 10 mL (2 teaspoonful)

    Active Ingredient (per 10 mL)

    Purpose

    Magnesium hydroxide 2400 mg

    Laxative

  • Active Ingredient per 10 mL

    Magnesium hydroxide 2400 mg

  • Purpose

    Laxative

  • Keep Out of Reach of Children

  • Warnings

    Ask a doctor before us if you have:

    Kidney disease
    Stomach pain, nausea or vomiting
    A magnesium restricted diet
    A sudden change in bowel habits that lasts over 14 days

    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 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 one week.

    If pregnant or breast-feeding, ask a health professional before use.

    In case of overdose, get medical help or contact a Poison Control Center right away.

    This package bears a tamper evident seal. If the seal is broken, do not use.

  • Suggested Uses

    Relieves occasional constipation (irregularity).

    This product usually produces bowel movement in 1/2 to 6 hours.

  • Directions

    Shake well before use – Do not dilute.
    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.

    Adults and Children 12 Years and Older

    10 to 20 mL (2 to 4 tsp.)

    Children 6 to 11 Years

    5 to 10 mL (1 to 2 tsp.)

    Children under 6 Years

    Ask a Doctor

  • Other Information

    10 mL contains: magnesium 1000 mg
    10 mL contains: sodium 21 mg
  • Storage and Handling

    Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

    Do not freeze, keep tightly closed.

  • Inactive Ingredients

    Benzyl alcohol, carboxymethylcellulose sodium, citric acid anhydrous, glycerin, lemon oil, purified water, sodium citrate, sodium hexametaphosphate, sodium hyprochlorite, sorbitol, sucrose, vanillin.

  • Questions or Comments?

    Call toll free 1-800-962-8364. You may also report serious side effects to this phone number

    Distr. by: West-Ward
    Pharmaceutical Corp.

    Eatontown, NJ 07724

    Revised August 2016

  • Package/Label Principal Display Panel

    fpl-label-400ml-07.jpg

    CONCENTRATED Milk of Magnesia (Lemon Flavored)

    0054-3567-61: Bottles of 400 mL

  • INGREDIENTS AND APPEARANCE
    MILK OF MAGNESIA 
    milk of magnesia concentrate
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0054-3567
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM HYDROXIDE2400 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LEMON OIL (UNII: I9GRO824LL)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  
    SORBITOL (UNII: 506T60A25R)  
    SUCROSE (UNII: C151H8M554)  
    VANILLIN (UNII: CHI530446X)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0054-3567-49100 mL in 1 BOTTLE; Type 0: Not a Combination Product03/12/2001
    2NDC:0054-3567-61400 mL in 1 BOTTLE; Type 0: Not a Combination Product03/12/2001
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33403/12/2001
    Labeler - West-Ward Pharmaceuticals Corp. (080189610)
    Registrant - Roxane Laboratories, Inc. (833490464)
    Establishment
    NameAddressID/FEIBusiness Operations
    West-Ward Columbus Inc.058839929MANUFACTURE(0054-3567)