Pleo Stroph
FDA Label NDC 60681-9011

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 Stroph (NDC 60681-9011). 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 active ingredients, inactive ingredients, tamper evident, dosage, 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.

Active Ingredients

30 mL Strophanthus g. 4X.

Inactive Ingredients

water, ethanol 51% V/V

Tamper Evident

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

Dosage

Acute

5 drops every half to full hour up to a max. of 12 times daily.

Chronic

5 drops up to 3 times daily.

Warning

If symptoms persist for more than a few days, contact a licensed practitioner right away. 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™ Stroph DROPS 4X

Homeopathic Healthy Heart Preparation

1 fl oz (30 mL)

DOSAGE: Acute: 5 drops every half to full hour up to a max. of 12 times daily. Chronic: 5 drops
up to 3 times daily. WARNING: If symptoms persists for more than a few days, contact a licensed
practitioner right away. 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: Active Ingredient: 30 mL
Strophanthus g. 4X, Inactive Ingredients: water, ethanol 51 % V/V.
Rev. 06/2009

Principal Display Panel (30 mL Label)

Principal Display Panel (30 mL Label)

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