Indications
For temporary relief of fever and minor inflammation.
Pleo Rec
FDA Label NDC 60681-3101
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 Rec (NDC 60681-3101). 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 - 5 ml label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Ingredients
5 mL Bacillus firmus 6X in a base of purified water.
Tamper Evident
Do not use this product if tamper-evident seal on base of bottle cap is missing or broken or if imprinted security strip on carton is torn.
Dosage
2–5 drops, 1–3 times weekly 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.
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
Principal Display Panel (5 mL Label)
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