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]

PURPOSE

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

1-2 x weekly 1 sip

INGREDIENTS

1 mL contains Bacillus firmus 6X, 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.

SPL UNCLASSIFIED SECTION

Made in Germany

Manufactured by:
SANUM-Kehlbeck GmbH & Co. KG,
Hoya, Germany

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

Rev. 08/2010

PRINCIPAL DISPLAY PANEL - 1 mL Label

3701-1

Pleo® Rec
PORTABLE SIPS 6X

OraI Homeopathic Medicine

The original
SANUM®
brand remedies

INDICATIONS: For temporary relief of
fever and minor inflammation.

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

DOSAGE: 1-2 x weekly 1 sip

INGREDIENTS: 1 mL contains Bacillus
firmus 6X, in a base of purified saline
solution.

Tamper Evident: Do not use this product
if the glass vial is broken.

ORIGINAL ENDERLEIN

convenient, disposable
single dose containers

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

Rev. 08/2010

660IN6XSE10US008

INGREDIENTS AND APPEARANCE

PLEO REC 
bacillus firmus liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60681-3701
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
bacillus firmus (UNII: D6U864H4DT) (bacillus firmus - UNII:D6U864H4DT)	bacillus firmus	6 [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: 60681-3701-1	10 in 1 CARTON
1		1 mL in 1 VIAL, GLASS
2	NDC: 60681-3701-2	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)