Indications
For nausea
Pleo Cup
FDA Label NDC 60681-1071
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 Cup (NDC 60681-1071). 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, inactive ingredient, 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
Inactive Ingredient
30 mL contains cuprous gluconate 3X in a base of purified water, ethanol (20%).
Tamper Evident
Do not use this product if tamper-evident seal on base of bottle cap is missing or broken.
Dosage
In case of acute conditions every half to one hour, not more than 6 × daily each 5 drops. In case of chronic forms 1-3 × daily 5 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.
Principal Display Panel - 30 Ml Label
Pleo® Cup
DROPS 3X
Homeopathic
Medicine
The original
SANUM®
brand remedies
Indications:
For nausea
1 fl oz
(30 mL)
Principal Display Panel (30 mL Label)
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