PLEO FORT- penicillium roqueforti solution/ drops

Pleo Fort by

Drug Labeling and Warnings

Pleo Fort by is a Homeopathic medication manufactured, distributed, or labeled by Sanum-Kehlbeck GmbH & Co. KG. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Homeopathic Digestive Aid Medicine

Indications

For temporary relief of digestive symptoms such as fullness, pressure, or "gas" that occur after eating.

INGREDIENTS

10 mL Penicillium roquefortii 5X in a base of purified water.

Tamper Evident

Do not use this product if tamper-evident seal on base of bottle cap is missing or broken or if imprinted security strip on carton is torn.

DOSAGE

5–10 drops, once daily.

WARNING

If symptoms persist more than a few days, contact a licensed practitioner. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health care professional before using this product.

Keep this and all other medications out of the reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

STORAGE AND HANDLING

Protect from light and heat.

SPL UNCLASSIFIED SECTION

Made in Germany

Distributed by:
SANUM USA Corp.
1465 Slater Road
Ferndale, WA 98248

Manufactured By:
Sanum-Kehlbeck,
GmbH & Co. KG

Rev. 12/2007

PRINCIPAL DISPLAY PANEL - 10 mL Label

Pleo™ Fort DROPS 5X

Homeopathic Digestive Aid Medicine

Indications: For temporary relief of digestive symptoms such as
fullness, pressure, or "gas" that occurs after eating.

0.34 fl oz (10 mL)

DOSAGE: 5–10 drops, once daily. WARNING: If symptoms persist more than a few
days, contact a licensed practitioner. As with any drug, if you are pregnant or nursing
a baby, seek the advice of a health care professional before using this product. Keep
this and all medications out of the reach of children. In case of accidental overdose,
seek professional assistance or contact a Poison Control Center immediately. Protect
from light and heat. TAMPER EVIDENT: Do not use this product if tamper-evident
seal on base of bottle cap is missing or broken. INGREDIENTS: 10 mL Penicillium
roquefortii 5X in a base of purified water.
Rev. 06/2009

PRINCIPAL DISPLAY PANEL - 10 mL box

Pleo™ Fort
DROPS 5X

Homeopathic
Digestive Aid
Medicine

lndications: For
temporary relief
of digestive
symptoms such
as fullness,
pressure, or
"gas" that occur
after eating.

ORIGINAL ENDERLEIN

0.34 fl oz
(10 mL)

INGREDIENTS AND APPEARANCE

PLEO FORT 
penicillium roqueforti solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60681-1101
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
penicillium roqueforti (UNII: 7ORP6R724L) (penicillium roqueforti - UNII:7ORP6R724L)	penicillium roqueforti	5 [HP_X]  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60681-1101-1	1 in 1 CARTON
1		10 mL in 1 BOTTLE, DROPPER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved homeopathic		03/19/1996

Labeler - Sanum-Kehlbeck GmbH & Co. KG (318386133)