Pleo Muscar: Homeopathic Product Information

PLEO MUSCAR- amanita muscaria whole liquid
Sanum-Kehlbeck GmbH & Co. KG

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Homeopathic Medicine

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.

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.

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
(click image for full-size original)
PLEO MUSCAR
amanita muscaria whole liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:60681-0801
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMANITA MUSCARIA WHOLE (AMANITA MUSCARIA WHOLE) AMANITA MUSCARIA WHOLE 6 [hp_X] in 10 mL
Inactive Ingredients
Ingredient Name Strength
WATER
ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60681-0801-2 1 BOTTLE in 1 CARTON contains a BOTTLE
1 10 mL in 1 BOTTLE This package is contained within the CARTON (60681-0801-2)
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 Operations
Sanum-Kehlbeck GmbH & Co. KG 318386133 MANUFACTURE (60681-0801)

Revised: 06/2012 Sanum-Kehlbeck GmbH & Co. KG

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