Label: PLEO UT S- mycobacterium phlei solution/ drops
-
Contains inactivated NDC Code(s)
NDC Code(s): 60681-5407-1, 60681-5407-2 - Packager: Sanum Kehlbeck GmbH & Co. KG
- Category: HUMAN OTC DRUG LABEL
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 March 9, 2012
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- PURPOSE
- INDICATIONS
- DIRECTIONS FOR USE
- DOSAGE
- INGREDIENTS
-
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
-
PRINCIPAL DISPLAY PANEL - 1 mL Carton
5407-1
Pleo® Ut "S"
PORTABLE SIPS 6X
Oral Homeopathic MedicineThe original
SANUM®
brand remediesINDICATIONS: For temporary relief of flu
symptoms.DIRECTIONS FOR USE: Snap off top
portion of sipping container. Insert glass
sipping straw.DOSAGE: 1–2 x weekly 1 sip.
INGREDIENTS: 1 mL contains Myco-
bacterium phlei 6X, 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. 12/2011
-
INGREDIENTS AND APPEARANCE
PLEO UT S
mycobacterium phlei solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60681-5407 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength mycobacterium phlei (UNII: T67520T45F) (mycobacterium phlei - UNII:T67520T45F) mycobacterium phlei 6 [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:60681-5407-1 10 in 1 CARTON 1 1 mL in 1 VIAL, GLASS 2 NDC:60681-5407-2 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 11/01/2005 Labeler - Sanum Kehlbeck GmbH & Co. KG (318386133)