Indications
For temporary relief of digestive symptoms such as fullness, pressure, or "gas" that occur after eating.
Pleo Fort
FDA Label NDC 60681-1101
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 60681-1101). 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 - 10 ml label, principal display panel - 10 ml box, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Ingredients
10 mL Penicillium roquefortii 5X in a base of purified water.
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
5–10 drops, once daily.
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 - 10 Ml Label
Pleo™ Fort DROPS 5X
Homeopathic Digestive Aid Medicine
Indications: For temporary relief of digestive symptoms such as
fullness, pressure, or "gas" that occurs after eating.
0.34 fl oz (10 mL)
DOSAGE: 5–10 drops, once daily. 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: 10 mL Penicillium
roquefortii 5X in a base of purified water.
Rev. 06/2009
Principal Display Panel (10 mL Label)
Principal Display Panel - 10 Ml Box
Pleo™ Fort
DROPS 5X
Homeopathic
Digestive Aid
Medicine
lndications: For
temporary relief
of digestive
symptoms such
as fullness,
pressure, or
"gas" that occur
after eating.
ORIGINAL ENDERLEIN
0.34 fl oz
(10 mL)
Principal Display Panel (10 mL box)
* Please review the disclaimer below.
