FDA Label for Milk Of Magnesia
View Indications, Usage & Precautions
Milk Of Magnesia Product Label
The following document was submitted to the FDA by the labeler of this product Mckesson Corporation Dba Sky Packaging. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient (In Each 5 Ml)
Magnesium hydroxide 400 mg
Purpose
Saline laxative
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
adults and children 12 years of age and over | 5 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)
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
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
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
adults and children 12 years and older | 30 mL (2 TBSP) to 60 mL (4 TBSP) |
children 6 – 11 years | 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 room temperature, 20° - 25°C (68° - 77°F). Avoid freezing.
- Milk of Magnesia USP (white suspension, spearmint flavor) is supplied in the following oral dosage form:
NDC 63739-196.01 | 30 mL unit dose cup. Case contains 100 unit dose cups of 30 mL packaged in 10 trays of 10 unit dose cups each. |
Inactive Ingredients
flavoring, hydroxypropyl methylcellulose, methylparaben, potassium citrate, propylene glycol, propylparaben, purified water, antifoam af emulsion, sodium saccharin, and sorbitol.
Questions Or Comments?
Call 1-800-845-8210
Principal Display Panel - 30 Ml Cup Tray Label
NDC 63739-196-01
Milk of Magnesia USP
ANTACID, SALINE LAXATIVE
Each 30 mL contains:
Magnesium Hydroxide
2400 mg
SHAKE WELL
USUAL DOSAGE: See attached Drug Facts
Package Not Child-Resistant
DISTRIBUTIONED BY
SKY Packaging
Memphis, TN 38141
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