Label: PLEO REC- bacillus firmus liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 60681-3105-1, 60681-3105-2 - 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 9, 2009
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- 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.
- Tamper Evident
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - 1 mL Label
3105-1
Pleo™ Rec
PORTABLE SIPS 4XOraI Homeopathic Medicine
INDICATIONS: For temporary relief of fe-
ver and minor inflammation.DIRECTIONS FOR USE: Snap off top
portion of sipping container. Insert glass
sipping straw.DOSAGE: 1 SlP, every two weeks.
INGREDIENTS: 1 mL contains Bacillus
firmus 4X, in a base of purified saline so-
lution.convenient, disposable
single dose containers10 doses, each 1 mL
(.03 fl oz)Rev. 5/99
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INGREDIENTS AND APPEARANCE
PLEO REC
bacillus firmus liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60681-3105 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength bacillus firmus (UNII: D6U864H4DT) (bacillus firmus - UNII:D6U864H4DT) bacillus firmus 4 [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:60681-3105-1 10 in 1 CARTON 1 1 mL in 1 VIAL, GLASS 2 NDC:60681-3105-2 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 03/19/1997 Labeler - Sanum Kehlbeck GmbH & Co. KG (318386133)