Active Ingredient
Magnesium sulfate USP 100%
Epsom Salt Granule
FDA Label NDC 55319-572
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Family Dollar (family Wellness) for the product Epsom Salt (NDC 55319-572). 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 use if you are, when using this product, stop use and ask a doctor if, if pregnancy 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 Use 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 Pregnancy 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 12 years and older | 2-4 level teaspoons dissolved in a full glass (8oz) of water |
| children 6 to 11 years | 1-2 level teaspoons in a full glass (8oz) of water |
Not recommended for children under 6 years of age.
Other Information
- each teaspoon contains: magnesium 495 mg
Inactive Ingredients
None
Questions Or Comments?
For laxative or soak, call 1-877-753-3935 Monday- Friday 9AM-5PM EST
Principal Display Panel
Epsom Salt
Magnesium Sulfate USP
Saline laxative
For external use
as a soaking solution
for relief of pain from
minor sprains and bruises
NET WT oz kg
TAMPER EVIDENT: DO NOT USE IF HEAT SEALED POUCH IS IMPROPERLY SEALED.
DISTRIBUTED BY:
MIDWOOD BRANDS, LLC
500 VOLVO PARKWAY
CHESAPEAKE, VA 23320
Package Label
FAMILY WELLNESS Epsom Salt
* Please review the disclaimer below.
