Label: PLEO SAN COLI- escherichia coli liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 60681-1225-1, 60681-1225-2 - 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 20, 2009
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- INDICATIONS
- DIRECTIONS FOR USE
- DOSAGE
- INGREDIENTS
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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.
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - 1 mL Carton
1225-2
Pleo™ San COLI
PORTABLE SIPS 7XOral Homeopathic Medicine
INDICATIONS: For temporary relief of
gastroenteritis symptoms.DIRECTIONS FOR USE: Snap off top
portion of sipping container. Insert glass
sipping straw.DOSAGE: 1 SIP, every 1–3 days.
INGREDIENTS: 1 mL contains Escheri-
chia coli 7X, in a base of purified saline
solution.convenient, disposable
single dose containers50 doses, each 1 mL
(.03 fl oz)Rev. 11/97
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INGREDIENTS AND APPEARANCE
PLEO SAN COLI
escherichia coli liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60681-1225 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength escherichia coli (UNII: 514B9K0L10) (escherichia coli - UNII:514B9K0L10) escherichia coli 7 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength sodium chloride (UNII: 451W47IQ8X) water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60681-1225-1 10 in 1 CARTON 1 1 mL in 1 VIAL, GLASS 2 NDC:60681-1225-2 50 in 1 CARTON 2 1 mL in 1 VIAL, GLASS Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED HOMEOPATHIC 05/24/2004 Labeler - Sanum Kehlbeck GmbH & Co. KG (318386133)