Pleo Ut S
FDA Label NDC 60681-5404

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 Ut S (NDC 60681-5404). 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 suppositories carton, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Indications

For temporary relief of flu symptoms.

Active Ingredient Per Dose

0.2 g Mycobacterium phlei 6X.

Inactive Ingredients

hydrogenated palm kernel glycerides, lactose.

Dosage

1–3 times weekly, 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 taking this product.

Tamper Evident

Do not use this product if imprinted inner blister pack is missing or broken.

Principal Display Panel - 10 Suppositories Carton

Pleo™ Ut "S"
SUPPOSITORIES 6X

Homeopathic Decongestant/
Bronchodilator Medicine

Indications: For temporary
relief of flu symptoms.

10 SUPPOSITORIES

Principal Display Panel (10 Suppositories Carton)

Principal Display Panel (10 Suppositories Carton)

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