Otc - Purpose
Homeopathic Medicine
Pleo Muscar
FDA Label NDC 60681-0801
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 60681-0801). 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 otc - purpose, indications, ingredients, tamper evident, dosage, otc - ask doctor, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indications
For pain associated with muscle cramps and migraine headaches, for occasional irritability and the symptoms of irritable "bowel syndrome".
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.
Otc - Ask Doctor
If symptoms persist more than a few days, contact a licensed practitioner.
Otc - Pregnancy Or Breast Feeding
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 other 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.
Other
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)
Principal Display Panel (10 mL Bottle Carton)
* Please review the disclaimer below.
