PLEO MUSCAR- amanita muscaria whole liquid

Pleo Muscar by

Drug Labeling and Warnings

Pleo Muscar 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

For pain associated with muscle cramps and migraine headaches, for occasional irritability and the symptoms of irritable "bowel syndrome".

ACTIVE INGREDIENT

INGREDIENTS

10 mL Amanita muscaria 6X in a base of purified water and alcohol 50% by volume.

Tamper Evident

Do not use this product if tamper-evident seal on base of bottle cap is missing or broken.

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 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

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

PRINCIPAL DISPLAY PANEL - 10 mL Bottle Carton

Pleo®
Muscar
DROPS 6X

Homeopathic
Medicine

The original
SANUM®

brand remedies

Indications: For pain
associated with muscle
cramps and migraine
headaches, for
occasional irritability
and the symptoms of
irritable "bowel
syndrome".

0.34 fl oz
(10 mL)

INGREDIENTS AND APPEARANCE

PLEO MUSCAR 
amanita muscaria whole liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60681-0801
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AMANITA MUSCARIA WHOLE (UNII: RQ7YY49K9Q) (AMANITA MUSCARIA WHOLE - UNII:RQ7YY49K9Q)	AMANITA MUSCARIA WHOLE	6 [hp_X]  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60681-0801-2	1 in 1 CARTON
1		10 mL in 1 BOTTLE

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(60681-0801)