Active Ingredient
Magnesium Hydroxide 400mg
Magnesium Hydroxide
FDA Label NDC 21695-903
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rebel Distributors Corp for the product Magnesium Hydroxide (NDC 21695-903). 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, keep out of reach of children, uses, warnings, other information, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Saline Laxative / Antacid
Keep Out Of Reach Of Children
In case of overdose, get medical help or contact a Poison Control Center right away.
Uses
Laxative: relieves occasional constipation; generally produces a bowel movement in 1/2 to 6 hours.
Antacid: relieves heartburn, sour stomach & acid indigestion.
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 2 weeks
Ask a doctor or pharmacist before use if you are taking any other drug.
° antacids may interact with certain prescription drugs ° laxatives may affect how other drugs work, so should be taken 2 or more hours before or after other drugs.
When using this product as an antacid, it may have a laxative effect.
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 ° symptoms last more than 2 weeks.
If pregnant or breast-feeding, ask a health professional before use.
Other Information
each 5 mL teaspoon contains: magnesium 165mg and sodium 2 mg
store at room temperature
protect from freezing
keep tightly closed
Directions
Laxative: ° shake well before using
° drink a full glass (8 ounces) of liquid with each dose
° may be taken as a single or divided dose
Antacid: ° do not take more than 12 teaspoons in 24 hours
° do not use maximum dosage for more than 2 weeks
Laxative:
adults and children 12 years and older: 2 to 4 tablespoons
children 6 to under 12 years: 1 to 2 tablespoons
children 2 to under 6 years: 1 to 3 teaspoons
children under 2 years: ask a doctor
Antacid:
adults and children 12 years and older: 1 to 3 teaspoons with water, up to 4 times daily
children under 12 years: ask a doctor
Inactive Ingredients
flavor, purified water, saccharin sodium, sodium hypochlorite
Questions or comments? Call 1-800-645-2158, 9 am - 5 pm EST, Monday-Friday
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Milk Of Magnesia (C29995d6 E8f2 4e7b Aa03 6ce5aa0e7710 01)
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