The following Structured Product Label (SPL) was submitted to the FDA by New Sun Inc. for the product Sinus Relief (NDC 66579-0026). 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 dosage & administration, warnings, otc - keep out of reach of children, other safety information, otc - purpose, otc - active ingredient, inactive ingredient, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Directions: Before initial dose depress pump 4-5 times or until primed and spray 1 dose directly in mouth 4 to 6 times daily until symptoms improve.
Adult Dose: 3 Pump Sprays
Child's Dose (2-12): 2 Pump Sprays
Infants - 2 yrs: 1 Pump Spray
Warnings: If symptoms persist or worsen, seek advice of physician. If pregnant or breast-feeding, take only on advice of physician.
Keep out of reach of children.
Other information: Tamper resistant for your protection. Use only if safety seal is intact.
Indications: For temporary relief of: sinus congestion • sinus pain • sinus headaches • mucus drainage • dry mucus membranes • stuffy nose • sneezing • upper respiratory allergies
Active Ingredients: 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, and 100X potencies.
Inactive Ingredient: Citric acid, potassium sorbate, purified water.
Indications: For temporary relief of:
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