Milk Of Magnesia Original
FDA Label NDC 64725-0649

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Tya Pharmaceuticals for the product Milk Of Magnesia Original (NDC 64725-0649). 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 tablespoonful), purpose, uses, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, 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 Tablespoonful)

Magnesium hydroxide 1200 mg

Purpose

Saline laxative

Uses

  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 1/2 to 6 hours

Warnings

• kidney disease • a magnesium-restricted diet • stomach pain, nausea, or vomiting • a sudden change in bowel habits that lasts over 14 days taking a prescription drug. This product may interact with certain prescription drugs. • 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 ask a health professional before 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,

Otc - Keep Out Of Reach Of Children

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

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 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: 2 to 4 tablespoonfuls children 6 to 11 years: 1 to 2 tablespoonfuls children under 6 years: ask a doctor









Other Information

• magnesium 500 mg • store at room temperature and avoid freezing • close cap tightly after use • each 15 mL tablespoonful contains:


TAMPER-EVIDENT: Do not use if imprinted neckband is missing or broken.

Inactive Ingredients

purified water, sodium hypochlorite

* Please review the disclaimer below.