Indications
For temporary relief of digestive symptoms such as fullness, pressure or "gas" that occur after eating.
Pleo Fort
FDA Label NDC 60681-1105
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 Fort (NDC 60681-1105). 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, inactive ingredient, warning, tamper evident, principal display panel - 10 vial 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 - 3x weekly 1 sip
Inactive Ingredient
1 mL contains Penicillium roquefortii 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.
Principal Display Panel - 10 Vial Carton
1105-1
Pleo® Fort
PORTABLE SIPS 5X
Oral Homeopathic Medicine
The original
SANUM®
brand remedies
INDICATIONS: For temporary relief of di-
gestive symptoms such as fullness, pres-
sure or "gas" that occur after eating.
DIRECTIONS FOR USE: Snap off top
portion of sipping container. Insert glass
sipping straw.
DOSAGE: 1 - 3x weekly 1 sip
INGREDIENTS: 1 mL contains Penicillium
roquefortii 5X, in a base of purified saline
solution.
Tamper Evident: Do not use this product
if the glass vial is broken.
ORIGINAL ENDERLEIN
convenient, disposable
single dose containers
10 doses, each 1 mL
(.03 fl oz)
Rev. 10/2002
300INSXSE10US912
Principal Display Panel (10 Vial Carton)
* Please review the disclaimer below.
