Pleo Rec
FDA Label NDC 60681-3105

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 Rec (NDC 60681-3105). 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 label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Indications

→ Directions For Use

→ Dosage

→ Ingredients

→ Warning

→ Tamper Evident

→ Principal Display Panel - 1 Ml Label

Indications

For temporary relief of fever and minor inflammation.

Directions For Use

Snap off top portion of sipping container. Insert glass sipping straw.

Dosage

1 SlP, every two weeks.

Ingredients

1 mL contains Bacillus firmus 4X, 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.