Indications
For temporary relief of menopausal symptoms.
Pleo Usti
FDA Label NDC 60681-5603
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 Usti (NDC 60681-5603). 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, directions for use, dosage, ingredients, warning, tamper evident, principal display panel - 1 ml carton, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Directions For Use
Snap off top portion of sipping container. Insert glass sipping straw.
Dosage
1 SIP, twice weekly.
Ingredients
1 mL contains Ustilago zeae e sporibus rec. 5X, in a base of purified saline solution.
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.
Tamper Evident
Do not use this product if the glass vial is broken or if imprinted security strip on carton is torn.
Principal Display Panel - 1 Ml Carton
5603-1
Pleo™ Usti
PORTABLE SIPS 5X
Oral Homeopathic Medicine
INDICATIONS: For temporary relief of
menopausal symptoms.
DIRECTIONS FOR USE: Snap off top
portion of sipping container. Insert glass
sipping straw.
DOSAGE: 1 SIP, twice weekly.
INGREDIENTS: 1 mL contains Ustilago
zeae e sporibus rec. 5X, in a base of puri-
fied saline solution.
convenient, disposable
single dose containers
10 doses, each 1 mL
(.03 fl oz)
Rev. 10/2002
Principal Display Panel (1 mL Carton)
* Please review the disclaimer below.
