Pleo Fort
FDA Label NDC 60681-1106

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 60681-1106). 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, active ingredient per dose, inactive ingredients, dosage, warning, tamper evident, principal display panel - 10 suppository carton, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Indications

For temporary relief of digestive symptoms such as fullness, pressure, or "gas" that occurs after eating.

Active Ingredient Per Dose

0.2 g Penicillium roquefortii 3X.

Inactive Ingredients

hydrogenated palm kernel glycerides, lactose.

Dosage

Once daily, insert one suppository rectally at bedtime.

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 imprinted inner plastic shell is broken or if imprinted security strip on carton package is torn.

Principal Display Panel - 10 Suppository Carton

Pleo™ Fort
SUPPOSITORIES 3X

Homeopathic Digestive Aid Medicine

Indications: For temporary relief
of digestive symptoms such as fullness,
pressure, or "gas" that occurs after eating.

ORIGINAL ENDERLEIN

10 SUPPOSITORIES

Principal Display Panel (10 Suppositories Carton)

Principal Display Panel (10 Suppositories Carton)

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