Label: PLEO REC- bacillus firmus solution/ drops
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Contains inactivated NDC Code(s)
NDC Code(s): 60681-3101-2 - 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 September 30, 2009
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Indications
- INGREDIENTS
- Tamper Evident
- DOSAGE
- WARNING
- STORAGE AND HANDLING
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - 5 mL Label
Pleo™ Rec DROPS 6X
Homeopathic Fever Reducer Medicine
Indications: For temporary relief of fever and minor inflammation.
0.17 fl oz (5 mL)
DOSAGE: 1-3x weekly 2-5 drops before mealtime. 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. Keep this and all medications out of 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: 5 mL Bacillus firmus 6X in a base of purified water.
Rev. 06/2009 -
INGREDIENTS AND APPEARANCE
PLEO REC
bacillus firmus solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60681-3101 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BACILLUS FIRMUS (UNII: D6U864H4DT) (BACILLUS FIRMUS - UNII:D6U864H4DT) BACILLUS FIRMUS 6 [hp_X] in 5 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60681-3101-2 1 in 1 CARTON 1 5 mL in 1 BOTTLE, DROPPER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved homeopathic 03/19/1996 Labeler - Sanum Kehlbeck GmbH & Co. KG (318386133)