Label: PLEO QUENT- penicillium glabrum solution/ drops
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Contains inactivated NDC Code(s)
NDC Code(s): 60681-2901-1 - 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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- SPL UNCLASSIFIED SECTION
- Indications
- INGREDIENTS
- Tamper Evident
- DOSAGE
- WARNING
- STORAGE AND HANDLING
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - 10 mL Label
Pleo™ Quent DROPS 5X
Homeopathic Decongestant Medicine
Indications: For temporary relief of bronchial and sinus congestion.
0.34 fl oz (10 mL)
DOSAGE: 5–10 drops, once daily, 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 other 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: 10 mL Penicillium
glabrum 5X in a base of purified water.
Rev. 06/2009
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INGREDIENTS AND APPEARANCE
PLEO QUENT
penicillium glabrum solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60681-2901 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PENICILLIUM GLABRUM (UNII: 2IN23YUE0I) (PENICILLIUM GLABRUM - UNII:2IN23YUE0I) PENICILLIUM GLABRUM 5 [hp_X] in 10 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60681-2901-1 1 in 1 CARTON 1 10 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)