Pleo Rec
FDA Label NDC 60681-3102

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 60681-3102). 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 other, indications, ingredients, other components, dosage, warning, tamper evident, principal display panel - capsule carton, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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Homeopathic Fever Reducer Medicine

5 CAPSULES

Made in Germany.

Distributed by:
SANUM USA Corp.
1465 Slater Road
Ferndale, WA 98248

Manufactured by:
Sanum-Kehlbeck
GmbH & Co. KG

Rev. 12/2004

Indications

For temporary relief of fever and minor inflammation.

Ingredients

1 capsule contains: 330 mg Bacillus firmus 4X in a base of lactose.

Other Components

Capsule shells consist of Hypromellose (HPMC).

Dosage

1–2 times weekly, one capsule either before breakfast or 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. 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 shrink-wrap is missing from the carton or the imprinted blister foil is broken.

Principal Display Panel - Capsule Carton

Pleo™ Rec
CAPSULES 4X

Homeopathic
Fever Reducer Medicine

Indications: For temporary relief
of fever and minor inflammation.

5 CAPSULES

Principal Display Panel (Capsule Carton)

Principal Display Panel (Capsule Carton)

* Please review the disclaimer below.