Fever - Infection Pellet
FDA Label NDC 55714-2441

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 Fever - Infection (NDC 55714-2441). 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.

Indications & Usage Section

Formulated for associated symptoms such as aches, chills, fatigue, sweating, nausea and loss of appetite.

Dosage & Administration Section

Directions: Ages 12 and up, take 6 pellets mouth (ages 0 to 11, give 3 pellets) as needed or as directed by a health professional. Under age 2, crush or dissolve pellets in purfied water. Sensitive persons begin with 1 pellet and gradually increase to full dose. Warning: If symptoms become severe or fever persists for more than 48 hours, consult a licensed health professional.

Otc - Active Ingredient Section

Equal parts of Apis mel. 6x, Echinacea 6x, Hydrastis 6x, Aconitum nap. 15x, Antimon. tart. 15x, Arnica 15x, Arsenicum alb. 15x, Baptisia 15x, Belladonna 15x, Bryonia 15x, Cantharis 15x, Chamomilla 15x, Cinchona 15x, Eupatorium perf. 15x, Ferrum metallicum 15x, Gelsemium 15x, Hepar sulph.calc. 15x, Iodium 15x, Lachesis 15x, Merc. viv. 15x, Phosphorus 15x, Pulsatilla 15x, Rhus toxicodendron 15x, Salix nigra 15x, Verbascum 15x, Anthracinum 30x, Influenzinum 30x, Pyrogenium 30x.

Otc - Purpose Section

Formulated for associated symptoms such as aches, chills, fatigue, sweating, nausea and loss of appetite

Inactive Ingredient Section

Inactive Ingredients: Gluten-Free, non-GMO, organic beet-derived sucrose (lactose-free) pellets.

Questions Section

newtonlabs.net - Question? 800.448.7256

Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

Warnings Section

WARNINGS: Keep out of reach of children. Do no use if tamper-evident seal is broken or missing. 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 (N004 P01)

Package Label (N004 P01)

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