Label: PLEO SAN STREP- streptococcus pyogenes liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 60681-1295-1, 60681-1295-2 - 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 11, 2011
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- PURPOSE
- 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 Vial Carton
1295-1
Pleo® San STREP
PORTABLE SIPS 5XOral Homeopathic Medicine
The original
SANUM®
brand remediesINDICATIONS: For temporary relief of
itching and congestion associated with
allergies.DIRECTIONS FOR USE: Snap off top
portion of sipping container. Insert glass
sipping straw.DOSAGE: 1-3 x weekly 1 sip
INGREDIENTS: 1 mL contains Streptococ-
cus pyogenes 5X, in a base of purified
saline solution.Tamper Evident: Do not use this product
if the glass vial is broken.convenient, disposable
single dose containers10 doses, each 1 mL
(.03 fl oz)Rev. 02/2011
215IN5XSE10US102
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INGREDIENTS AND APPEARANCE
PLEO SAN STREP
streptococcus pyogenes liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60681-1295 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength streptococcus pyogenes (UNII: LJ2LP0YL98) (streptococcus pyogenes - UNII:LJ2LP0YL98) streptococcus pyogenes 5 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) sodium chloride (UNII: 451W47IQ8X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60681-1295-1 10 in 1 CARTON 1 1 mL in 1 VIAL, GLASS 2 NDC:60681-1295-2 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 04/30/1997 Labeler - Sanum Kehlbeck GmbH & Co. KG (318386133)