Active Ingredient
Magnesium sulfate USP (heptahydrate) 100%
Epsom Salt Granule
FDA Label NDC 21130-970
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Safeway, Inc. for the product Epsom Salt (NDC 21130-970). 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
- for relief of occasional constipation (irregularity)
- this product 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) immediately.
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 dissolved 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 495 mg
Questions Or Comments?
For laxative or soak, call 1-877-753-3935 Monday- Friday 9AM-5PM EST
Principal Display Panel
EPSOM SALTS
Magnesium Sulfate U.S.P.
Mg SO4 + 7H2O
Soaking aid for minor sprains & bruises
Saline laxative for relief of occasional constipation
For external use as a soaking aid for minor sprains and bruises
CAUTION: IF PROMPT RELIEF IS NOT OBTAINED OR THERE IS EVIDENCE OF INFECTION. DISCONTINUE USE AND CONSULT YOUR PHYSICIAN. HOT OR WARM SOAKS SHOULD NOT BE USED BY INDIVIDUALS WITH DIABETES EXCEPT ON THE ADVISE OF A PHYSICIAN. KEEP OUT OF REACH OF CHILDREN.
STORE IN COOL DRY PLACE OUT OF DIRECT SUNLIGHT. PACKAGE SOLD BY WEIGHT NOT VOLUME. SOME SETTLING OF CONTENT MAY OCCUR DURING SHIPMENT. IF CAKING OCCURS, TAP POUCH GENTLE TO FREE GRANULES
NET WT OZ (LB) kg
Tamper Evident Packaging: Caution: this package has been sealed for your protection. Do not use if package is open, torn or mutilated
DISTRIBUTED BY:
BETTER LIVING BRANDS LLC
P.O. BOX 99, PLEASANTON, CA 94566-0009
Package Label
SIGNATURE CARE Epsom Salt
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