Indications
For temporary relief of constipation, mild cramping, bloating and gas
Subtilis
FDA Label NDC 49693-2301
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 Subtilis (NDC 49693-2301). 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, otc - keep out of reach of children, storage and handling, tamper evident, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Dosage
5 drops, three times per week.
Active Ingredient
Bacillus subtilis 6X
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.
Otc - Keep Out Of Reach Of Children
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.
Storage And Handling
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.
Principal Display Panel - 5 Ml Label
SUBTILIS DROPS 6X
Homeopathic Medicine 0.17 fl. oz. (5ml)
Indications: For temporary relief of constipation, mild cramping, bloating and gas
Dosage: 5 drops, three times per week.
Active Ingredient: Bacillus subtilis 6X
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: 1-623-582-3110
Principal Display Panel (5 mL Label)
* Please review the disclaimer below.
