FDA Label for Milk Of Magnesia

View Indications, Usage & Precautions

Milk Of Magnesia Product Label

The following document was submitted to the FDA by the labeler of this product Physicians Total Care, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredients



Magnesium hydroxide 1200 mg


Purpose



Saline laxative


Uses



  • relieves occasional constipation (irregularity)
    • usually 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 over 14 days


Ask A Doctor Or Pharmacist Before Use If You Are



taking any other drug.  Take this product 2 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 1 week

If Pregnant Or Breast-Feeding



ask a health professional before use.


Keep This And All Drugs Out Of The Reach Of Children



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


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, in divided doses, or as directed by a doctor
        • drink a full glass (8oz) of liquid with each dose
        • adults and children 12 years and older
          2 to 4 tabletspoonfuls (TBSP)
          children 6 to 11 years
          1 to 2 tablespoonfuls (TBSP)
          children under 6 years
          ask a doctor



Other Information



  • each 15 mL tablespoonful contains:  magnesium 500 mg
    • store at room temperature and avoid freezing
      • close cap tightly after use
        • TAMPER-EVIDENT:  Do not use if imprinted neckband is missing or broken.


Inactive Ingredients



flavor, purified water, saccharin sodium, sodium hypochlorite


Principal Display Panel



Compare to Active Ingredient inPhillips Milk of MagnesiaRugby Milk of Magnesia is distributed byRugby Laboratories, Inc.Duluth, GA   30097Additional barcode labeling by;Physicians Total Care, Inc.Tulsa, Oklahoma    74146Milk of MagnesiaMagnesium Hydroxide 1200mgSaline LaxativeMint FlavorNet Contents16 fl oz (473 mL)

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