Pleo Cal
FDA Label NDC 60681-0113

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 Cal (NDC 60681-0113). 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 otc - purpose, indications, ingredients, tamper evident, dosage, otc - ask doctor, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Purpose

Homeopathic Medicine

Indications

To reduce bleeding from cuts and scrapes.

Ingredients

One tablet contains 250 mg Calvatia gigantea 4X in a base of lactose, potato starch, magnesium stearate.

Tamper Evident

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

Dosage

1-3 × daily 1 tablet.

Otc - Ask Doctor

If symptoms persist more than a few days, contact a licensed practitioner.

Otc - Pregnancy Or Breast Feeding

As with any drug, if you are pregnant or nursing a baby, seek the advice of a health care professional before using this product.

Otc - Keep Out Of Reach Of Children

Keep this and all other medications out of the reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

Storage And Handling

Protect from light and heat.

Other

Manufactured by: Sanum-Kehlbeck GmbH & Co. KG Hoya, Germany

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

Principal Display Panel - Blister Pack Carton

Pleo® Cal
TABLETS 4X

Homeopathic
Medicine

The original
SANUM®
brand remedies

Indications: To reduce bleeding from
cuts and scrapes.

80 TABLETS

Principal Display Panel (Blister Pack Carton)

Principal Display Panel (Blister Pack Carton)

* Please review the disclaimer below.