Active Ingredient
Magnesium sulfate USP 100%
Epsom Salt
FDA Label NDC 43221-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Frog Prince(china)daily Chemicals Co., Ltd. for the product Epsom Salt (NDC 43221-001). 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, uses, ask a doctor before use if you have, ask a doctor or pharmacist before using if you are, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Saline laxative
Uses
■ relieves occasional constipation (irregularity)
■ generally produces bowel movement in 1/2 to 6 hours
Ask A Doctor Before Use If You Have
■ kidney disease ■ a magnesium restricted diet ■ stomach pain, nausea or vomiting ■ noticed a sudden change in bowel habits that lasts more than 2 weeks
Ask A Doctor Or Pharmacist Before Using If You Are
presently taking a prescription drug
When Using This Product
■ do not use more than directed
Stop Use And Ask A Doctor If
■ you have rectal bleeding or failure to have a bowel movement after use. This may indicate a serious condition.
■ you need to use a laxative for more than 1 week.
If Pregnant Or Breast-Feeding
ask a health professional before use
Keep Out Of Reach Of Children
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away
Directions
■do not exceed more than 2 doses per day; if necessary repeat dosage in 4 hours
age dose
adults and children 2-4 level teaspoons dissolved
12 years and older in a full glass (8oz) of water
children 6 to 1-2 level teaspoons dissolved
11 years in a full glass (8oz) of water
Not recommended for children under 6 years of age
Inactive Ingredients
NONE
Other Information
■ each teaspoon contains magnesium 493 mg
* Please review the disclaimer below.
