Active Ingredient
Magnesium Hydroxide 400 mg per teaspoon (5 mL)
Premier Value Milk Of Magnesia Suspension
FDA Label NDC 68016-850
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pharmacy Value Alliance, Llc for the product Premier Value Milk Of Magnesia (NDC 68016-850). 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, purpose, use, warnings ask a doctor before use if you have., stop use and ask a doctor., when using this product., keep out of reach of children., directions (shake well before use), and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antacid/Saline Laxative
Use
As an antacid: helps relieve acid ingestion, heartburn and sour stomach.
As a laxative: For the temporary relief of occasional constipation. Bowel movement is generally produced in 1.2 to 6 hours.
Warnings Ask A Doctor Before Use If You Have.
Abdominal pain, nausea, vomiting, kidney desease, are on a magnesium restricted diet, a sudden change in bowel habits lasting longer than 14 days, if you are taking prescription drugs. Antacids may interact with certain prescription drugs.
Stop Use And Ask A Doctor.
If you have rectal bleeding or have no bowel movement after using this product. this could be signs of a serious codition, if you need to use a laxative for more than one week. Frequent or prolonged use may result in the dependence on laxatives.
When Using This Product.
As an antacid, do not take more than the maximum recomended daily dose in a 24 hr. period or take the maximum dose for more than two weeks, except under the advise of a doctor. May have laxative effect.
If pregnant or breastfeeding ask a health professional before use.
Keep Out Of Reach Of Children.
In the case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.
Directions (Shake Well Before Use)
As an antacid: Adults and children 12 yrs. of age and older: 1 to 3 teaspoonfuls with a little water, or as directed by a doctor.
As a laxative: Adults and children 12 yrs. of age and older: 1 to 4 tablespoonfuls followed by a full 8 oz. glass of water.
Children 6 thru 11 yr. of age: 1 to 2 tablespoonfuls followed by a full 8 oz. glass of water.
children 2 thru 5 yrs. of age: 1 to 3 teaspoonfuls followed by a full 8 oz. glass of water.
Children under 2 yrs. of age: consult a doctor before use.
Other Information
acid neutralizing capacilty: 10.0 mEq per teaspoon.
keep tightly closed and avoid freezing.
Inactive Ingredient.
Purified water
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