Active Ingredient
Magnesium sulfate USP 100%
Epsom Salt Granule
FDA Label NDC 36800-395
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Top Care (topco Associates Llc) for the product Epsom Salt (NDC 36800-395). 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 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 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 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 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 Ingredient
none
Principal Display Panel
FOR HEALTH & BEAUTY
Epsom Salt
MAGNESIUM SULFATE USP
- a soaking aid for minor sprains & bruises
- a saline laxative for the short-term relief of constipation
NET WT OZ (LB)
TAMPER EVIDENT: DO NOT USE IF HEAT SEALED CARTON IS IMPROPERLY SEALED.
DISTRIBUTED BY TOPCO ASSOCIATES LLC
©ELK GROVE VILLAGE, IL 60007
TOPCO PLV1117
Package Label
TOPCARE Epsom Salt
* Please review the disclaimer below.
