Otc - Active Ingredient
Active Ingredients Purpose
Magnesium Sulfate [heptahydrate]100% Saline Laxative
Epsom Salts
FDA Label NDC 22431-124
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Blue Cross Laboratories, Inc. for the product Epsom Salts (NDC 22431-124). 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
-For relief of occasional constipation (irregularity)
-this product generally produces bowel movement in 1/2 to 6 hours
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
Indications & Usage
-For relief of occasional constipation (irregularity)
-this product generally produces bowel movement in 1/2 to 6 hours
Warnings
Warnings
Ask a doctor is 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 longer than 1 week
Ask a doctor of pharmacist before use if you are taking any other drug. Take this product 2 or more hours before or after other drugs. Laxatives may affect how other drugs work.
If pregnant or breast-feeding, as a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
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
Other information
Magnesium content: 495 mg per teaspoon
Package Label.Principal Display Panel
Relief
Epsom Salt
Magnesium Sulfate
A Soaking aid for minor sprains & bruises
Use as a saline laxative
NET WT 16 Oz (1 LB) 454 g
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