Indications
For relief of diarrhea and stomach upset.
Pleo Spermus
FDA Label NDC 60681-1311
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 Spermus (NDC 60681-1311). 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 contains: Leptospermum scoparium 1X in a base of purified water, ethanol (70%).
Tamper Evident
Use this product only if tamper-evident strip on base of bottle cap is intact.
Dosage
Take 5 drops, 1–3 times daily, unless otherwise recommended by your health care professional.
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 - 30 Ml Label
Pleo™ Spermus DROPS 1X
Homeopathic Medicine
Indications: For relief of diarrhea and stomach upset.
1 fl oz (30 mL)
DOSAGE: Take 5 drops 1-3 times daily; unless otherwise recommended by your health care
professional. WARNING: If symptoms persist, contact a licensed practitioner. If pregnant or
nursing, seek advice of a health care professional before use. 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: Leptospermum scoparium 1X in a base of purified water,
ethanol (70 %).
Rev. 06/2009
Principal Display Panel (30 mL Label)
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