Indications
For temporary relief of acute diarrhea.
Pleo Oku
FDA Label NDC 60681-2401
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 Oku (NDC 60681-2401). 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.
Label Section Quick Index
Ingredients
30 mL Okoubaka aubrevillei 2X 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 or if imprinted security strip on carton is torn.
Acute
5 drops, every ½ to 1 hour;
Chronic
5 drops, 1-3 times daily.
Warning
lf symptoms persist more than a few days, contact a licensed practitioner. As with any other 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™ Oku DROPS 2X
Homeopathic Antidiarrheal Medicine
Indications: For temporary relief of acute diarrhea.
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 other
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: Okoubaka aubrevillei 2X in a base of purified water, ethanol (70 %). Rev. 06/2009
Principal Display Panel (30 mL Label)
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