PLEO CAL- calvatia gigantea whole tablet

Pleo Cal by

Drug Labeling and Warnings

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

Drug Details [pdf]

PURPOSE

Homeopathic Medicine

Indications

To reduce bleeding from cuts and scrapes.

ACTIVE INGREDIENT

INGREDIENTS

One tablet contains 250 mg Calvatia gigantea 4X in a base of lactose, potato starch, magnesium stearate.

Tamper Evident

Do not use this product if imprinted inner blister pack is broken.

DOSAGE

1-3 × daily 1 tablet.

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 overdose, seek professional assistance or contact a Poison Control Center immediately.

Protect from light and heat.

SPL UNCLASSIFIED SECTION

Manufactured by: Sanum-Kehlbeck GmbH & Co. KG Hoya, Germany

SPL UNCLASSIFIED SECTION

Distributed by: SANUM USA Corp. 1465 Slater Road Ferndale, WA 98248

PRINCIPAL DISPLAY PANEL - Blister Pack Carton

Pleo® Cal
TABLETS 4X

Homeopathic
Medicine

The original
SANUM®
brand remedies

Indications: To reduce bleeding from
cuts and scrapes.

80 TABLETS

INGREDIENTS AND APPEARANCE

PLEO CAL 
calvatia gigantea whole tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60681-0113
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALVATIA GIGANTEA WHOLE (UNII: BR6B7CG29T) (CALVATIA GIGANTEA WHOLE - UNII:BR6B7CG29T)	CALVATIA GIGANTEA WHOLE	4 [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: 60681-0113-1	8 in 1 CARTON
1		10 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED HOMEOPATHIC		07/10/2012

Labeler - Sanum-Kehlbeck GmbH & Co. KG (318386133)

Establishment
Name	Address	ID/FEI	Business Operations
Sanum-Kehlbeck GmbH & Co. KG		318386133	MANUFACTURE(60681-0113)