SUBTILIS- bacillus subtilis liquid

Subtilis by

Drug Labeling and Warnings

Subtilis by is a Homeopathic medication manufactured, distributed, or labeled by USPharmaCo, DermaMed. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Homeopathic Medicine

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.

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.

SPL UNCLASSIFIED SECTION

To report serious adverse events, call: 1-623-582-3110

Manufactured for and distributed by:
USPharmaCo Distribution Ltd.
2205 W. Lone Cactus Drive #19, Phoenix, AZ 85027
www.uspharmaco.com
info@uspharmaco.com

Made in Canada

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

INGREDIENTS AND APPEARANCE

SUBTILIS 
bacillus subtilis liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49693-2301
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Bacillus subtilis (UNII: 8CF93KW41W) (Bacillus subtilis - UNII:8CF93KW41W)	Bacillus subtilis	6 [hp_X]  in 5 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49693-2301-1	1 in 1 BOX
1		5 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED HOMEOPATHIC		12/15/2009

Labeler - USPharmaCo (145322622)

Establishment
Name	Address	ID/FEI	Business Operations
DermaMed		256799461	MANUFACTURE