PLEO STROPH- strophanthus hispidus solution/ drops

Pleo Stroph by

Drug Labeling and Warnings

Pleo Stroph by is a Homeopathic medication manufactured, distributed, or labeled by Sanum Kehlbeck GmbH & Co. KG. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Homeopathic Preparation for a Healthy Heart

1 fl oz
(30 mL)

ACTIVE INGREDIENTS

30 mL Strophanthus g. 4X.

INACTIVE INGREDIENTS

water, ethanol 51% V/V

Tamper Evident

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

DOSAGE

Acute

5 drops every half to full hour up to a max. of 12 times daily.

Chronic

5 drops up to 3 times daily.

WARNING

If symptoms persist for more than a few days, contact a licensed practitioner right away. 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 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

Made in Germany.

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

Manufactured By:
Sanum-Kehlbeck
GmbH & Co. KG

Rev. 08/2005

PRINCIPAL DISPLAY PANEL - 30 mL Label

Pleo™ Stroph DROPS 4X

Homeopathic Healthy Heart Preparation

1 fl oz (30 mL)

DOSAGE: Acute: 5 drops every half to full hour up to a max. of 12 times daily. Chronic: 5 drops
up to 3 times daily. WARNING: If symptoms persists for more than a few days, contact a licensed
practitioner right away. 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 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. TAMPER EVIDENT: Do not use this product if tamper-
evident seal on base of bottle cap is missing or broken. INGREDIENTS: Active Ingredient: 30 mL
Strophanthus g. 4X, Inactive Ingredients: water, ethanol 51 % V/V.
Rev. 06/2009

INGREDIENTS AND APPEARANCE

PLEO STROPH 
strophanthus hispidus solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60681-9011
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
strophanthus hispidus (UNII: MO892VI77K) (strophanthus hispidus - UNII:MO892VI77K)	strophanthus hispidus	4 [hp_X]  in 30 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: 60681-9011-1	1 in 1 CARTON
1		30 mL in 1 BOTTLE, DROPPER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved homeopathic		02/21/2006

Labeler - Sanum Kehlbeck GmbH & Co. KG (318386133)