Pleo Cerivi
FDA Label NDC 60681-7001

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 Cerivi (NDC 60681-7001). 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 - 30 ml label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Indications

For temporary relief of sinus congestion, laryngitis, and sore throat symptoms.

Ingredients

30 mL contains Cetraria islandica 1X in a base of purified water, ethanol (70%).

Tamper Evident

Do not use this product if tamper-evident seal on base of bottle cap is missing or broken.

Dosage

Acute: 5 drops, every ½ to 1 hour. Chronic: 5 drops, 1-3 times daily, unless otherwise recommended by your health care professional.

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 - 30 Ml Label

Pleo™ Cerivi DROPS 1X

Homeopathic Medicine

Indications: For temporary relief of sinus congestion, laryngitis,
and sore throat symptoms.

1 fl oz (30 mL)

DOSAGE: Acute: 5 drops, every ½ to 1 hour; chronic: 5 drops, 1-3 times 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: 30 mL Cetraria islandica 1X in a base of purified
water, ethanol (70%).
Rev. 06/2009

Principal Display Panel (30 mL Label)

Principal Display Panel (30 mL Label)

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