PLEO NIG- aspergillus niger var. niger capsule

Pleo Nig by

Drug Labeling and Warnings

Pleo Nig by is a Homeopathic medication manufactured, distributed, or labeled by Sanum Kehlbeck GmbH & Co. KG. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

SPL UNCLASSIFIED SECTION

Homeopathic Antipruritic Medicine

20 CAPSULES

Indications

For temporary relief of external itching and soreness in the urogenital region.

INGREDIENTS

1 capsule contains 330 mg Aspergillus niger 4X.

Inactive ingredients

Lactose, Capsule shells consist of Hypromellose (HPMC).

Tamper Evident

Do not use this product, if imprinted inner blister pack is broken or if imprinted security strip on carton is torn.

DOSAGE

1–3 capsules daily, either before breakfast or 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 taking 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. 03/2008

PRINCIPAL DISPLAY PANEL - 20 Capsules Carton

Pleo™ Nig
CAPSULES 4X

Homeopathic
Antipruritic Medicine

Indications: For temporary
relief of external itching
and soreness in the
urogenital region.

ORIGINAL ENDERLEIN

20 CAPSULES

INGREDIENTS AND APPEARANCE

PLEO NIG 
aspergillus niger var. niger capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60681-2103
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
aspergillus niger var. niger (UNII: 9IOA40ANG6) (aspergillus niger var. niger - UNII:9IOA40ANG6)	aspergillus niger var. niger	4 [HP_X]

Inactive Ingredients
Ingredient Name	Strength
lactose (UNII: J2B2A4N98G)
hypromellose (UNII: 3NXW29V3WO)

Product Characteristics
Color	YELLOW	Score	no score
Shape	CAPSULE	Size	19mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60681-2103-1	1 in 1 CARTON
1		20 in 1 BLISTER 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)