Other
CII
Codeinum
FDA Label NDC 10191-1034
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Remedy Makers for the product Codeinum (NDC 10191-1034). 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 other, warning:, indication:, directions (adult/children), other information:, warnings and precautions, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Warning:
'The FDA has not determined that the product is safe, effective and not misbranded for its intended use"
Use only if cap and seal are unbroken. Keep this and all medication out of reach of children. If symptoms persist for more than 3 days or worsen, discontinue (STOP) use and consult your physician. As with any drug. If you are pregnant or nursing (breast-feeding) a baby, seek the advise of a health professional before using this product. Store tightly closed in a cool area.
Indication:
ITCHING WITH WARMTH SPASMODIC COUGH, OR OTHER INDICATIONS
Directions (Adult/Children)
Disolve 3 or 4 pellets in mouth or under tongue 3 times a day or as directed by a physician. Children 2 years and older take 1/2 adult dose.
Other Information:
Contains approx. 165 - 168 pellets.
Warnings And Precautions
CAUTION: Federal law prohibits dispensing without prescription.
Package Label.Principal Display Panel
Codeinum6x (Codeinum6x)
* Please review the disclaimer below.
