Pleo Muscar
FDA Label NDC 60681-0802

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sanum Kehlbeck Gmbh & Co. Kg for the product Pleo Muscar (NDC 60681-0802). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, indications, directions for use, dosage, ingredients, otc - do not use, otc - keep out of reach of children, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Other

Oral Homeopathic Medicine

50 doses, each 1 mL
(.03 fl oz)

Made in Germany

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

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

Rev. 03/2010

Indications

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

Directions For Use

Snap off top portion of sipping container. Insert glass sipping straw.

Dosage

acute: 1-2 ml 3 times daily. chronic diseases: 1-2 times daily.

Ingredients

1 mL contains Amanita muscaria e thallo 6X in a base of purified saline solution.

Otc - Do Not Use

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.

Otc - Keep Out Of Reach Of Children

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 glass vial is broken.

Principal Display Panel - 1 Ml Vial Carton

0802-2

Pleo® Muscar

PORTABLE SIPS 6X

Oral 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".

DIRECTIONS FOR USE: Snap off top
portion of sipping container. Insert glass
sipping straw.

DOSAGE: acute: 1-2 ml 3 times daily.
chronic diseases: 1-2 times daily.

INGREDIENTS: 1 mL contains Amanita
muscaria e thallo 6X in a base of purified
saline solution.

convenient, disposable
single dose containers

50 doses, each 1 mL
(.03 fl oz)

Rev. 03/2010

Principal Display Panel (1 mL Vial Carton)

Principal Display Panel (1 mL Vial Carton)

* Please review the disclaimer below.