Sinusitis
FDA Label NDC 55714-4419

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Newton Laboratories, Inc. for the product Sinusitis (NDC 55714-4419). 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 indications & usage section, dosage & administration section, active ingredient section, purpose section, inactive ingredient section, questions? section, warnings section, pregnancy or breast feeding section, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Indications & Usage Section

Sinusitis  Formulated for symptoms of acute or chronic sinusitis associated with allergies and bacterial or fungal infections.

Dosage & Administration Section

Directions:  Ages 12 and up, take 6 pellets orally (ages 0 to 11, give 3 pellets) one to four times daily or as directed by a healthcare professional.  Under age 2, crush or dissolve pellets in purified water.

Active Ingredient Section

Arsenicum iodatum 15x, Bryonia 15x, Cistus canadensis 15x, Hepar sulph. calc. 15x, Histaminum hydrochloricum 15x, Hydrastis 15x, Iodium 15x, Kali bic. 15x, Kali iod.15x, Merc. iod. rub. 15x, Merc. viv. 15x, Nux vom. 15x, Phosphorus 15x, Pulsatilla 15x, Sabadilla 15x, Sticta 15x, Verbascum 15x , Echinacea 3x, Hydrastis 3x.

Purpose Section

Formulated for symptoms of acute or chronic sinusitis associated with allergies and bacterial or fungal infections.

Inactive Ingredient Section

Inactive Ingredients:  Gluten-free, non-GMO, beet-derived sucrose pellets.

Questions? Section

www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions?  1.800.448.7256

Warnings Section

Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children.

Pregnancy Or Breast Feeding Section

Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days

Keep Out Of Reach Of Children Section

Keep out of reach of children.

Package Label

Package Label (R010 P01)

Package Label (R010 P01)

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