Guna-oral Spray
FDA Label NDC 17089-452

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Guna Spa for the product Guna-oral (NDC 17089-452). 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 active ingredients/purpose, uses, warnings, pregnancy, directions, questions, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients/Purpose

ACONITUM NAPELLUS       3X    ANTI-INFLAMMATORY
ARNICA MONTANA            3X    FEVER RELIEF
BELLADONNA                    4X    SWELLING
ECHINACEA ANGUSTIFOLIA    2X    BACTERIAL INFECTION
ECHINACEA PURPUREA        2X    IMMUNE REGULATION
HAMAMELIS VIRGINIANA       2X    SUPPORTS TISSUE REPAIR
HEPAR SULFURIS CALCAREUM 6X    ANTIBACTERIAL IMMUNE SUPPORT
HYPERICUM PERFORATUM    3X    ANALGESIC
MILLEFOLIUM                        3X    ORAL ANTI- INFLAMMATORY
SYMPHYTUM OFFICINALE    6X    ORAL HYPERSENSITIVITY
TEETH                                    12X    TOOTH HYPERSENSITIVITY

Uses


For the temporary relief of  symptoms due to Oro-pharyngeal Inflammatory conditions (Pharyngitis, Gingivitis, or Stomatitis) such as: throat pain, sensitive teeth, mouth pain, hoarseness

Warnings

Stop use and ask doctor if symptoms of throat pain and hoarseness worsen or persist more than  3 days

Keep this and all medicines out of reach of children

Pregnancy

If pregnant or breast-feeding ask a doctor before use

Directions

Adults and children 12 years and older                2 sprays to back of throat, 3-5 times per day
Children between 12 years and 6 years of age    1 spray to back of throat, 3-5 times per day
Children under 6 years                                     1 spray to back of throat, 3 times per day

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