Indications & Usage Section
Formulated for associated symptoms of late Summer and Fall pollens such as nasal catarrh, post-nasal drip, sneezing, glandular swelling and pharyngitis.
Hay Fever
FDA Label NDC 55714-4432
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 Hay Fever (NDC 55714-4432). 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, otc - active ingredient section, otc - purpose section, inactive ingredient section, questions section, warnings section, otc - pregnancy or breast feeding section, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Dosage & Administration Section
Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) as needed or as directed by a health professional.
Otc - Active Ingredient Section
Xerophyllum 30x, Alfalfa 15x, Allersodes 15x, Allium cepa 15x, Ambrosia 15x, Ammon. carb. 15x, Aralia rac. 15x, Arsenicum alb. 15x, Artemisia 15x, Bellis 15x, Berber. vulg. 15x, Bryonia 15x , Chelidonium maj. 15x, Eupatorium perf. 15x, Euphrasia 15x, Gelsemium 15x, Hepar sulph. calc. 15x, Histaminum hydrochloricum 15x, Kali bic. 15x, Kali iod. 15x, Lachesis 15x, Lycopodium 15x, Nat.mur. 15x, Sabadilla 15x, Solidago 15x, Trillium 15x, Ustilago maidis 15x, Apis mel. 3x, Echinacea 3x, Hydrastis 3x, Taraxacum 3x.
Otc - Purpose Section
Formulated for associated symptoms of late Summer and Fall pollens such as nasal catarrh, post-nasal drip, sneezing, glandular swelling and pharyngitis.
Inactive Ingredient Section
Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane dispensing alcohol 20%.
Questions Section
www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions? 1.800.448.7256
Warnings Section
Warning: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.
Otc - Pregnancy Or Breast Feeding Section
If pregnant or breast-feeding, ask a doctor before use.
Otc - Keep Out Of Reach Of Children Section
Keep out of reach of children.
Package Label
Package Label (R017 L01)
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