Indications
For temporary relief of headaches.
Pleo Usnea
FDA Label NDC 60681-5101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sanum Kehlbeck Gmbh & Co. Kg for the product Pleo Usnea (NDC 60681-5101). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding indications, ingredients, tamper evident, dosage, warning, principal display panel - 30 ml label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Ingredients
30 mL Usnea barbata 1X in a base of purified water, ethanol (70%).
Tamper Evident
Do not use this product if the tamper evident seat at base of bottle cap is missing or broken.
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 other drugs, if you are pregnant or nursing a baby, seek the advice of a health care professional before using this product.
Principal Display Panel - 30 Ml Label
Pleo™ Usnea DROPS 1X
Homeopathic Analgesic Medicine
Indications: For temporary relief of headaches.
1 fl oz (30 mL)
DOSAGE: Acute: 5 drops, every 1/2 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 contains: Usnea barbata 1X in a base
of purified water, ethanol (70 %).
Rev. 06/2009
Principal Display Panel 30 mL Label (Pleo Usnea 01)
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