PLEO REC- bacillus firmus suppository

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

10 SUPPOSITORIES

Indications

For temporary relief of fever and minor inflammation.

ACTIVE INGREDIENT PER DOSE

0.2 g Bacillus firmus 6X.

Inactive ingredients

hydrogenated palm kernel glycerides, lactose.

DOSAGE

1–3 times weekly, insert one suppository rectally at bedtime.

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 other medications out of the reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

STORAGE AND HANDLING

Protect from light and heat.

Tamper Evident

Use this product only if inner blister pack is intact.

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. 10/2002

PRINCIPAL DISPLAY PANEL - 10 Suppository Carton

Pleo™ Rec
SUPPOSITORIES 6X

Homeopathic Fever
Reducer Medicine

Indications: For temporary relief
of fever and minor inflammation.

10 SUPPOSITORIES

INGREDIENTS AND APPEARANCE

PLEO REC 
bacillus firmus suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60681-3104
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
bacillus firmus (UNII: D6U864H4DT) (bacillus firmus - UNII:D6U864H4DT)	bacillus firmus	6 [HP_X]

Inactive Ingredients
Ingredient Name	Strength
lactose (UNII: J2B2A4N98G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60681-3104-1	1 in 1 CARTON
1		10 in 1 DOSE PACK

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)