Pleo Relivora
FDA Label NDC 60681-6200

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 Relivora (NDC 60681-6200). 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, acute, chronic, 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 coughs and symptoms of bronchitis.

Ingredients

30 mL contains 0.75 mL Drosera 3X, 0.075 mL Echinacea angustifolia 2X, 7.5 mL Juglans 4X, water, ethanol (28%).

Tamper Evident

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

Acute

15 drops every two hours, up to 6 times daily.

Chronic

20-25 drops, 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™ Relivora DROPS 2X , 3X, 4X

Homeopathic Medicine

Indications: For temporary relief of coughs and symptoms of bronchitis.

1 fl oz (30 mL)

DOSAGE: Acute: 15 drops every 2 hours, up to 6 times daily. Chronic: 20-25 drops, 3 times daily,
unless otherwise recommended by your health care professional. WARNING: If symptoms persist,
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 contains:
0.75 mL Drosera 3X, 0.075 mL Echinacea angustifolia 2X, 7.5 mL Juglans 4X in a base of purified
water, ethanol (28 %).
Rev. 06/2009

Principal Display Panel (Pleo Relivora 01)

Principal Display Panel (Pleo Relivora 01)

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