Nuvalu Epsom Salt Granule
FDA Label NDC 72520-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by J C Sales for the product Nuvalu Epsom Salt (NDC 72520-001). 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 drug facts, active ingredients, purpose, uses, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Magnesium sulfate (heptahydrate) 100%
Purpose
Saline laxative
Uses
- relieves occasional constipation (irregularity)
- generally produces bowel movement in 30 mins 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 lasts more than 2 weeks
Ask a doctor or pharmacist before using if you are
presently taking a prescription drug. Laxatives may affect how other drugs work.
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
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
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.
Other Information
- magnesium content 493 mg per teaspoon (5 grams)
Store in cool dry place out of direct sunlight.
Inactive Ingredients
none
Packaging
Epsom001 (Label)
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