Active Ingredient (In Each 5 Ml)
Magnesium hydroxide 400 mg
Milk Of Magnesia Suspension
FDA Label NDC 81033-014
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kesin Pharma Corporation for the product Milk Of Magnesia (NDC 81033-014). 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 5 ml), purpose, indications & usage, as an antacid:, as a laxative (usually within ½ to 6 hours):, warnings, 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
Purpose
Saline laxative
Indications & Usage
Uses
As An Antacid:
- heartburn
- upset/sour stomach
- acid indigestion
- do not exceed the maximum recommended daily dose in a 24 hour period
- shake well before use
- can be taken with water
- mL = milliliter
| Age | Dose |
| adults and children 12 years of age and over | 5 mL to 15 mL (1 to 3 teaspoonfuls) |
| children under 12 years of age | ask a doctor |
As A Laxative (Usually Within ½ To 6 Hours):
- occasional constipation (irregularity)
Warnings
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
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.
Dosage & Administration
Directions
As A Laxative
- do not exceed the maximum recommended daily dose of 60 mL 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 = Tablespoon
| Age | Dose |
| adults and children 12 years and older | 30 mL (2 TBSP) to 60 mL (4 TBSP) |
| children 6 to 11 years of age | 15 mL (1 TBSP) to 30 mL (2 TBSP) |
| children under 6 years | ask a doctor |
Other Information
- each teaspoonful (5 mL) contains: magnesium 400 mg
- store at 20°C to 25°C (68°F to 77°F).
- Avoid freezing
- Protect from light
- Milk of Magnesia, USP is a milky-white cherry flavored suspension supplied in the following oral dosage forms:
NDC 81033-014-30: 30 mL unit-dose cup
NDC 81033-014-52: Case containing 100 unit-dose cups of 30 mL each.
Inactive Ingredients
cherry flavor, fumed silica, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sorbitol solution, sucralose, xanthan gum
Questions Or Comments?
Call 1-833-537-4679
Other
Distributed by:
Kesin Pharma
Oldsmar, FL 34677
PIS-014-V01
Rev. 09/2025
Principal Display Panel - 30 Ml Cup Tray Label
NDC 81033-014-52
Milk of Magnesia, USP 2400 mg per 30 mL
Delivers 30 mL
Case = 100 UD Cups
Milk Of Magnesia 30 mL Case Label 100 Ct (Milkofmag 30ml Case 100ct)
* Please review the disclaimer below.
