Otc - Active Ingredient
Active Ingredients Purpose
Magnesium Sulfate (heptahydrate) 100% Saline Laxative
Epsom Salts Granule
FDA Label NDC 52862-203
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by International Wholesale Inc. for the product Epsom Salts (NDC 52862-203). 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 otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Uses
- For relief of Occasional Constipation (Irregularity)
- This product generally produces bowel movement
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.
Indications & Usage
Ask a doctor or pharmacist before use if you are taking any other drug. Take this product 2 or more hours before or after any other drugs. Laxative may affect how other drugs work.
Warnings
Warnings
Ask a doctor before use if you have
- Kidney Disease
- A magnesium restricted diet
- Abdominal pain, nausea or vomiting
- Noticed a sudden change in bowel habits that persists over a period of 2 weeks
- Already used a laxative for a period of longer than 1 week
If pregnant or breast-feeding ask a health profesional before use
Dosage & Administration
Directions
- do not exceed more than 2 doses per day
- drink a full glass (8 ounces) of liquid with each dose
- dissolve the dose in 8 ounces of water. Lemon juice may be added to improve the taste.
- adults and children 12 years and over: 2 to 4 level teaspoons (10 to 20 grams) daily
- children 6 to under 12 years: 1 to 2 level teaspoons (5 to 10 grams) daily
- children under 6 years: consult a doctor
Inactive Ingredient
There are no inactive ingredients
Package Label.Principal Display Panel
Mutli purpose
Epsom Salts
Net Wt. 16 oz (454 g)
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