Label: PLEO CERIVI- cetraria islandica subsp. islandica solution/ drops
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Contains inactivated NDC Code(s)
NDC Code(s): 60681-7001-3 - 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 December 21, 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 - 30 mL Label
Pleo™ Cerivi DROPS 1X
Homeopathic Medicine
Indications: For temporary relief of sinus congestion, laryngitis,
and sore throat symptoms.1 fl oz (30 mL)
DOSAGE: Acute: 5 drops, every ½ to 1 hour; chronic: 5 drops, 1-3 times daily. 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 the 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: 30 mL Cetraria islandica 1X in a base of purified
water, ethanol (70%).
Rev. 06/2009
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INGREDIENTS AND APPEARANCE
PLEO CERIVI
cetraria islandica subsp. islandica solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60681-7001 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Cetraria islandica subsp. islandica (UNII: BJ7YPN79A1) (Cetraria islandica subsp. islandica - UNII:BJ7YPN79A1) Cetraria islandica subsp. islandica 1 [hp_X] in 30 mL Inactive Ingredients Ingredient Name Strength alcohol (UNII: 3K9958V90M) water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60681-7001-3 1 in 1 CARTON 1 30 mL in 1 BOTTLE, DROPPER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED HOMEOPATHIC 12/31/1997 Labeler - Sanum Kehlbeck GmbH & Co. KG (318386133)