Indications
For temporary relief from digestive discomfort
Roqueforti
FDA Label NDC 49693-1801
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Uspharmaco for the product Roqueforti (NDC 49693-1801). 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 indications, dosage, active ingredient, inactive ingredients, warning, tamper evident, principal display panel - 10 ml label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Dosage
5-10 drops, three times daily.
Active Ingredient
Penicillium roqueforti 4X
Inactive Ingredients
Purified water, sodium chloride, potassium sorbate.
Warning
If symptoms persist more than a few days, contact a licensed practitioner. As with any drug, if you are pregnant or nursing, seek the advice of a health care professional before using this product.
Tamper Evident
Do not use product if the tamper evident strip is broken or removed from the base of the cap.
Principal Display Panel - 10 Ml Label
ROQUEFORTI DROPS 4X
Homeopathic Medicine 0.34 fl. oz. (10ml)
Indications: For temporary relief from digestive discomfort
Dosage: 5-10 drops, three times daily.
Active Ingredient: Penicillium roqueforti 4X
Inactive Ingredients: Purified water, sodium chloride, potassium sorbate.
Warning: If symptoms persist more than a few days, contact a licensed practitioner. As with
any drug, if you are pregnant or nursing, seek the advice of a health care professional before
using this product. Keep this and all medications out of reach of children. In case of overdose,
get medical help or contact a Poison Control Center right away.Protect from light and heat.
Tamper Evident: Do not use product if the tamper evident strip is broken or removed from the
base of the cap.
To report serious adverse events, call: 1-877-557-4276 or 1-623-582-3110
Principal Display Panel (5 mL Label)
* Please review the disclaimer below.
