PLEO CAL- calvatia gigantea whole tablet 
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.

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Pleo® Cal TABLETS 4X

Homeopathic Medicine

Indications

To reduce bleeding from cuts and scrapes.

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.

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

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

Principal Display Panel - Blister Pack Carton
PLEO CAL 
calvatia gigantea whole tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60681-0113
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALVATIA GIGANTEA WHOLE (UNII: BR6B7CG29T) (CALVATIA GIGANTEA WHOLE - UNII:BR6B7CG29T) CALVATIA GIGANTEA WHOLE4 [hp_X]
Inactive Ingredients
Ingredient NameStrength
LACTOSE (UNII: J2B2A4N98G)  
STARCH, POTATO (UNII: 8I089SAH3T)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize4mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60681-0113-18 in 1 CARTON
110 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED HOMEOPATHIC07/10/2012
Labeler - Sanum-Kehlbeck GmbH & Co. KG (318386133)
Establishment
NameAddressID/FEIBusiness Operations
Sanum-Kehlbeck GmbH & Co. KG318386133MANUFACTURE(60681-0113)

Revised: 6/2012
Document Id: 97db8584-c5e0-4d6b-8435-566f7614a27b
Set id: ef8f32e7-9d13-4237-910c-7c3b6610a42b
Version: 1
Effective Time: 20120626
 
Sanum-Kehlbeck GmbH & Co. KG