PLEO REC- bacillus firmus solution/ drops

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

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.

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. 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

INGREDIENTS AND APPEARANCE

PLEO REC 
bacillus firmus solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60681-3101
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 5 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60681-3101-2	1 in 1 CARTON
1		5 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)