PLEO NOT- penicillium chrysogenum var. chrysogenum solution/ drops

Pleo Not by

Drug Labeling and Warnings

Pleo Not 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/Cough Suppressant/Decongestant Medicine

Indications

For temporary relief of coughs, fever and congestion due to colds and minor respiratory infections.

INGREDIENTS

10 mL Penicillium chrysogenum 5X 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

5–10 drops, once daily, 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. 05/2007

PRINCIPAL DISPLAY PANEL - 10 mL Label

Pleo™ Not DROPS 5X

Homeopathic Fever Reducer / Cough Suppressant / Decongestant Medicine

Indications: For temporary relief of coughs, fever and congestion
due to colds and minor respiratory infections.

0.34 fl oz (10 mL)

DOSAGE: 5–10 drops, once daily, 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. TAMPER EVIDENT: Do not use this product if tamper-evident
seal on base of bottle cap is missing or broken. INGREDIENTS: 10 mL Penicillium
chrysogenum 5X in a base of purified water.
Rev. 06/2009

PRINCIPAL DISPLAY PANEL - 10 mL box

Pleo™ Not
DROPS 5X

Homeopathic
Fever Reducer/
Cough
Suppressant/
Decongestant
Medicine

lndications: For
temporary relief
of coughs, fever
and congestion
due to colds and
minor respiratory
infections.

ORIGINAL ENDERLEIN

0.34 fl oz
(10 mL)

INGREDIENTS AND APPEARANCE

PLEO NOT 
penicillium chrysogenum var. chrysogenum solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60681-2301
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
penicillium chrysogenum var. chrysogenum (UNII: 3Y1PE1GCIG) (penicillium chrysogenum var. chrysogenum - UNII:3Y1PE1GCIG)	penicillium chrysogenum var. chrysogenum	5 [HP_X]  in 10 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60681-2301-1	1 in 1 CARTON
1		10 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)