Indications
For temporary relief of fever and minor inflammation.
Pleo Rec
FDA Label NDC 60681-3701
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 Rec (NDC 60681-3701). 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, directions for use, dosage, inactive ingredient, warning, tamper evident, principal display panel - 1 ml label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Directions For Use
Snap off top portion of sipping container. Insert glass sipping straw.
Dosage
1-2 x weekly 1 sip
Inactive Ingredient
1 mL contains Bacillus firmus 6X, in a base of purified saline solution.
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.
Tamper Evident
Do not use this product if the glass vial is broken.
Principal Display Panel - 1 Ml Label
3701-1
Pleo® Rec
PORTABLE SIPS 6X
OraI Homeopathic Medicine
The original
SANUM®
brand remedies
INDICATIONS: For temporary relief of
fever and minor inflammation.
DIRECTIONS FOR USE: Snap off top
portion of sipping container. Insert glass
sipping straw.
DOSAGE: 1-2 x weekly 1 sip
INGREDIENTS: 1 mL contains Bacillus
firmus 6X, in a base of purified saline
solution.
Tamper Evident: Do not use this product
if the glass vial is broken.
ORIGINAL ENDERLEIN
convenient, disposable
single dose containers
10 doses, each 1 mL
(.03 fl oz)
Rev. 08/2010
660IN6XSE10US008
Principal Display Panel (1 mL Label)
* Please review the disclaimer below.
