Otc - Purpose
Homeopathic Antidiarrheal Medicine
The following Structured Product Label (SPL) was submitted to the FDA by Sanum-kehlbeck Gmbh & Co. Kg for the product Pleo Oku (NDC 60681-2402). 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, acute, chronic, warning, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Homeopathic Antidiarrheal Medicine
For temporary relief of acute diarrhea.
One tablet contains 250 mg Okoubaka aubrevillei 2X in a base of lactose, potato starch, magnesium stearate.
Do not use this product if imprinted inner blister pack is broken.
1 tablet every half to full hour up to a max. of 12 times daily.
2 tablets daily.
lf 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 other medications out of the reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.
Rev. 04/2012
Manufactured by:
Sanum-Kehlbeck
GmbH & Co. KG
Hoya, Germany
Distributed by:
SANUM USA Corp.
1465 Slater Road
Ferndale, WA 98248
* Please review the disclaimer below.