Label: PLEO STROPH- strophanthus hispidus solution/ drops
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Contains inactivated NDC Code(s)
NDC Code(s): 60681-9011-1 - Packager: Sanum Kehlbeck GmbH & Co. KG
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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.
Drug Label Information
Updated November 30, 2009
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENTS
- Tamper Evident
- DOSAGE
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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.
- SPL UNCLASSIFIED SECTION
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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
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INGREDIENTS AND APPEARANCE
PLEO STROPH
strophanthus hispidus solution/ dropsProduct 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)