Olive Leaf Throat
FDA Label NDC 64616-037

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Vitality Works, Inc. for the product Olive Leaf Throat (NDC 64616-037). 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 olive leaf throat spray, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Olive Leaf Throat Spray

Wild Indigo (Baptisia tinctoria) 4X

Olive Leaf Extract (Olea europaea), Glycerin, USP Purified Water, Xylitol.

Do not exceed recommended dosage. This product may cause temporary discomfort such as mild burning and stinging in mouth and throat. The use of this container by more than one person may spread infection. For you safety there is a full body seal over bottle printed "sealed for your protection". Do not use if seal is broken or missing. If pregnant or breast feeding, ask a health care professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

A homeopathic remedy for the temporary relief of mouth and throat irritations.

Remove protective cap. With you head held upright, hold container close to mouth and depress pump completely. When finished, wipe nozzle clean and replace cap.

Adults and children 13 years and older - 1-3 sprays in mouth, every 2-4 hours or as needed.

Children 3-12 years - Half the adult dose.

Childern under 3 - Consult health care professional.

Wild Indigo (Baptisia tinctoria) - relieves redness and constriction, offensive discharge, painless sore throat, difficulty in swallowing, teeth and gums sore, ulcerated.

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