Nuvalu Epsom Salt Granule
FDA Label NDC 72520-002
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 72520-002). 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
- For relief of occasional constipation (irregularity)
- This product 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
• Abdominal pain, nausea or vomiting
• Notice a sudden change in bowel habits that persists over a period of 2 weeks
• Already used a laxative for a period longer than 1 week
Ask a doctor or pharmacist before use if you are
taking any other prescription drugs. Laxatives may affect how other drugs work
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
- Drink a full glass (8 ounces) of liquid with each dose
- Dissolve the dose in 8 ounces of water.
Lemon juice may be added to improve the taste.
| adults and children 12 years and over | 2 to 4 level teaspoons (10 to 20 grams) daily |
| children 6 to under 12 years | 1 to 2 level teaspoons (5 to 10 grams) daily |
| children under 6 years | consult a doctor |
Other Information
- magnesium content 493 mg per teaspoon (5 grams)
Inactive Ingredients
none
Packaging
Epsom002 (Label)
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