The following Structured Product Label (SPL) was submitted to the FDA by Pharmwest Inc. for the product Sinus Relief (NDC 50441-0003). 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 otc - active ingredient, inactive ingredient, indications & usage, dosage & administration, warnings, otc - keep out of reach of children, other safety information, otc - purpose, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Ingredients: (Official HPUS) Apis mellifica, Baptisia tinctoria, Colocynthis, Hepar sulphuris calcareum, Histaminum hydrochloricum, Hydrastis canadensis, Ignatia amara, Kali bichromicum, Lemna minor, Mercurius vivus, Pulsatilla, Rhus toxicodendron, Sabadilla, Thuja occidentalis. Equal volumes of each ingredient in: 10X, 30X, LM1 potencies.
Inactive Ingredients: Citric acid, potassium sorbate, pure water base.
Uses: For the temporary relief of symptoms due to inflamed sinuses, cold/flu nasal symptoms, sneezing, hay fever, allergies, runny nose, sinus pain, congestion and pressure, sinus headache, itchy, burning eyes, mucous drainage, sore throat and dry cough. Will not cause drowsiness.
Directions: Spray directly into mouth. Adult dose- 3 pump sprays 3 times daily. Children's Dose, (ages 2-12) 3 pump sprays, 3 times daily. Use additionally as needed.
Warnings: If symptoms persist or worsen, stop usage and consult a physician. If pregnant or breast-feeding, take only upon advice of a healthcare professional.
Keep out of the reach of children.
Tamper resistant for your protection. Use only if safety seal is intact.
Uses: For the temporary relief of symptoms due to inflamed sinuses
Will not cause drowsiness.
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