Milk Of Magnesia
FDA Label NDC 54868-2345

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Physicians Total Care, Inc. for the product Milk Of Magnesia (NDC 54868-2345). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, ask a doctor or pharmacist before use if you are, stop use and ask a doctor if, if pregnant or breast-feeding, keep this and all drugs out of the reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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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