Ingredients
100mL solution contains L-Lactic acid (4X, 6X, 12X, 30X, 200X, in equal amounts), in a base of purified water, alcohol 12.4% by volume.
Pleo Sanuvis
FDA Label NDC 60681-6300
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 Sanuvis (NDC 60681-6300). 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 ingredients, tamper evident, dosage, warning, principal display panel - 100 ml label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
1-3 × daily 5-20 drops.
Warning
If symptoms persist more than a few days, contact a licensed practitioner. As with any other drug, if you are pregnant or nursing a baby, seek the advice of a health care professional before using this product.
Principal Display Panel - 100 Ml Label
Pleo™ Sanuvis
HOMEOPATHIC DIGESTIVE AID
Lactic Acid
3.38 fl oz (100 mL)
DOSAGE: 1–3 x daily 5–20 drops. 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: 100 mL solution contains
L(+)-Lactic acid (4X, 6 X, 12X, 30X, 200X, in equal amounts), water, alcohol 12.4% by
volume.
Rev. 06/2009
Principal Display Panel (100 mL Label)
* Please review the disclaimer below.
