Milk Of Magnesia
FDA Label NDC 53807-125

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rij Pharmaceutical Corporation for the product Milk Of Magnesia (NDC 53807-125). 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 ingredient (in each 15 ml tablespoon), purpose, use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, stop use and ask a doctor if, if pregnant or breast-feeding,, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each 15 Ml Tablespoon)

Magnesium Hydroxide 1200 mg

Purpose

Saline laxative

Use

  • relieves occasional constipation (irregularity).
  • This product generally produces bowel movement in ½ to 6 hours.

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 more than 14 days

Ask A Doctor Or Pharmacist Before Use If You Are

taking a prescription drug. This product may interact with certain prescription drugs.

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.

Keep Out Of Reach Of Children.

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

Directions

  • do not exceed the maximum recommended daily dose in a 24 hour period
  • shake well before use
  • 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
  • mL = milliliter, TBSP = Tablespoonful

    • adults and children 12 years and older

    30 mL (2 TBSP) to 60 mL (4 TBSP)

    children 6 to 11 years

    15 mL (1 TBSP) to 30 mL (2 TBSP)

    children under 6 years

    ask a doctor

Other Information

  • TAMPER EVIDENT: Do not use if breakaway band on cap is broken or missing.
  • Store at room temperature 15° - 30°C (59° - 86°F)
  • keep tightly closed
  • keep from freezing
  • each tablespoon (15 mL) contains: magnesium 498 mg
  • each tablespoon (15 mL) contains: sodium 3 mg

Inactive Ingredients

citric acid, purified water, sodium hypochlorite

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