Milk Of Magnesia Concentrate Suspension
FDA Label NDC 0121-0940

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pai Holdings, Llc Dba Pai Pharma for the product Milk Of Magnesia Concentrate (NDC 0121-0940). 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 other, active ingredient (in each 10 ml), purpose, as an antacid, as a laxative, otc - do not use, ask a doctor before use if you have, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

MANUFACTURED BY

Pharmaceutical
Associates, Inc.
Greenville, SC 29605
www.paipharma.com

R07/21

Active Ingredient (In Each 10 Ml)

Magnesium hydroxide 2400 mg

Purpose

Saline laxative

As An Antacid

  • heartburn
  • upset/sour stomach
  • acid indigestion
    • do not exceed the maximum recommended daily dose of 20 mL in a 24 hour period
    • shake well before use
    • can be taken with water
    • mL = milliliter
      • adults and children 12 years of age and over5 mL (1 teaspoonful)
      children under 12 years of ageask a doctor

As A Laxative

  • relieves occasional constipation (irregularity) This product usually produces bowel movement in ½ to 6 hours.
    • 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
      • adults and children 12 years and older15 mL to 30 mL
      children under 12 yearsask a doctor

Otc - Do Not Use

Do not use if you have ever had an allergic reaction to this product or any of its ingredients

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

Otc - Ask Doctor/Pharmacist

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 1 week

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

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

Other Information

  • each teaspoonful (5 mL) contains: magnesium 1000 mg
  • Sodium Content: 19 mg/10 mL
  • store at room temperature, 20° - 25°C (68° - 77°F). Avoid freezing.
  • Milk of Magnesia Concentrate (white suspension, lemon flavored) is supplied in the following oral dosage form:

    • NDC 0121-0940-10: 10 mL unit dose cup, in a tray of ten cups.

Inactive Ingredients

glycerin, hydroxypropyl methylcellulose, lemon oil, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate
dihydrate, sodium saccharin, sorbitol, and sucrose.

Questions Or Comments?

Call 1-800-845-8210

Principal Display Panel - 10 Ml Unit-Dose Cup Tray Label

NDC 0121-0940-10

Milk of Magnesia Concentrate

Each 10 mL contains:

Magnesium Hydroxide 2400 mg.

ANTACID/ SALINE LAXATIVE

SHAKE WELL

Package Not Child-Resistant

See Insert

Principal Display Panel (10 mL Unit-Dose Cup Tray Label)

Principal Display Panel (10 mL Unit-Dose Cup Tray Label)

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