PLEO REC- bacillus firmus solution/ drops 
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
DROPS 6X

Homeopathic Fever Reducer Medicine

0.17 fl oz
(5 mL)

Indications

For temporary relief of fever and minor inflammation.

INGREDIENTS

5 mL Bacillus firmus 6X 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

2–5 drops, 1–3 times weekly before mealtime.

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.

Made in Germany

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

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

Rev. 05/2006

PRINCIPAL DISPLAY PANEL - 5 mL Label

Pleo™ Rec DROPS 6X

Homeopathic Fever Reducer Medicine

Indications: For temporary relief of fever and minor inflammation.

0.17 fl oz (5 mL)

DOSAGE: 1-3x weekly 2-5 drops before mealtime. 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 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: 5 mL Bacillus firmus 6X in a base of purified water.
Rev. 06/2009

Principal Display Panel - 5 mL Label
PLEO REC 
bacillus firmus solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60681-3101
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACILLUS FIRMUS (UNII: D6U864H4DT) (BACILLUS FIRMUS - UNII:D6U864H4DT) BACILLUS FIRMUS6 [hp_X]  in 5 mL
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60681-3101-21 in 1 CARTON
15 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved homeopathic03/19/1996
Labeler - Sanum Kehlbeck GmbH & Co. KG (318386133)

Revised: 9/2009
Document Id: 710a9906-e7bb-49e1-986e-a15eff2bf99a
Set id: eccda292-6e04-4c12-8e40-c7aa5ac488b4
Version: 1
Effective Time: 20090930
 
Sanum Kehlbeck GmbH & Co. KG