Active Ingredient
Magnesium Sulfate USP (Epsom Salt)
Winco Pure 5lb Crystal
FDA Label NDC 67091-477
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Winco Foods, Llc for the product Winco Pure 5lb (NDC 67091-477). 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, warnings, otc - ask doctor/pharmacist, warnings and precautions, otc - ask doctor, otc - 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
Warnings
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 last more than 2 weeks
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are presently taking a prescription drug.
Warnings And Precautions
When using this product
- do not use more than directed
Otc - Ask Doctor
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
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keept his and all drugs out of the 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 6-11 years | 1-2 level teaspoons dissolved in a full glass (8oz) of water |
Not recommended for children under 6 years of age
Other Information
- each teaspoon contains: magnesium 493mg
Inactive Ingredients
none
Questions?
Call 1-800-824-1706
Monday - Friday 9am-4pm MT
Principle Display Panel
Epsom Salt
MAGNESIUM SULFATE
SALINE LAXATIVE
For External Use as a Soaking Solution
For Minor Sprains & Bruises
Net Wt OZ (lb) kg
TAMPER EVIDENT: DO NOT USE IF HEAT SEALED POUCH IS IMPROPERLY SEALED.
DISTRIBUTED BY: WINCO FOODS LLC, BOISE, ID 83704
www.wincofoods.com
Package Label
WinCo Primary Packaging
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