PLEO REC- bacillus firmus liquid 
Sanum Kehlbeck GmbH & Co. KG

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Pleo™ Rec
PORTABLE SIPS 4X

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.

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

Principal Display Panel - 1 mL Label
PLEO REC 
bacillus firmus liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60681-3105
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
bacillus firmus (UNII: D6U864H4DT) (bacillus firmus - UNII:D6U864H4DT) bacillus firmus4 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
sodium chloride (UNII: 451W47IQ8X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60681-3105-110 in 1 CARTON
11 mL in 1 VIAL, GLASS
2NDC:60681-3105-250 in 1 CARTON
21 mL in 1 VIAL, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved homeopathic03/19/1997
Labeler - Sanum Kehlbeck GmbH & Co. KG (318386133)

Revised: 11/2009
Document Id: 7ba62913-b6ac-47d9-8dd8-1ae54a7f1a36
Set id: c7f1f977-a752-4da7-a775-1cc22cd81336
Version: 1
Effective Time: 20091109
 
Sanum Kehlbeck GmbH & Co. KG