PLEO REC- bacillus firmus liquid

Pleo Rec by

Drug Labeling and Warnings

Pleo Rec 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

Oral Homeopathic Medicine

10 doses, each 1 mL
(.03 fl oz)

INDICATIONS

For temporary relief of fever and minor inflammation.

DIRECTIONS FOR USE

Snap off top portion of sipping container. Insert glass sipping straw.

DOSAGE

1 SlP, every two weeks.

INGREDIENTS

1 mL contains Bacillus firmus 4X, in a base of purified saline solution.

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 the glass vial is broken or if imprinted security strip on carton is torn.

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. 5/99

PRINCIPAL DISPLAY PANEL - 1 mL Label

3105-1

Pleo™ Rec
PORTABLE SIPS 4X

OraI Homeopathic Medicine

INDICATIONS: For temporary relief of fe-
ver and minor inflammation.

DIRECTIONS FOR USE: Snap off top
portion of sipping container. Insert glass
sipping straw.

DOSAGE: 1 SlP, every two weeks.

INGREDIENTS: 1 mL contains Bacillus
firmus 4X, in a base of purified saline so-
lution.

convenient, disposable
single dose containers

10 doses, each 1 mL
(.03 fl oz)

Rev. 5/99

INGREDIENTS AND APPEARANCE

PLEO REC 
bacillus firmus liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60681-3105
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
bacillus firmus (UNII: D6U864H4DT) (bacillus firmus - UNII:D6U864H4DT)	bacillus firmus	4 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
sodium chloride (UNII: 451W47IQ8X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60681-3105-1	10 in 1 CARTON
1		1 mL in 1 VIAL, GLASS
2	NDC: 60681-3105-2	50 in 1 CARTON
2		1 mL in 1 VIAL, GLASS

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved homeopathic		03/19/1997

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