PLEO NIG- aspergillus niger var. niger tablet

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]

SPL UNCLASSIFIED SECTION

Homeopathic Antipruritic Medicine

20 TABLETS

Indications

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

INGREDIENTS

1 tablet contains 250 mg Aspergillus niger 5X in a base of lactose, potato starch, magnesium stearate.

DOSAGE

1–3 tablets daily, either two hours before breakfast or at bedtime.

WARNING

If symptoms persist more than a few days, contact your 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.

Tamper Evident

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

Lot #:

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 Tablets Carton

Pleo™ Nig
TABLETS 5X

Homeopathic
Antipruritic Medicine

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

ORIGINAL ENDERLEIN

20 TABLETS

INGREDIENTS AND APPEARANCE

PLEO NIG 
aspergillus niger var. niger tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60681-2102
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	5 [HP_X]

Inactive Ingredients
Ingredient Name	Strength
lactose (UNII: J2B2A4N98G)
Starch, Potato (UNII: 8I089SAH3T)
Magnesium Stearate (UNII: 70097M6I30)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	4mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60681-2102-1	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)