Indications & Usage Section
Formulated for associated symptoms such as itching, swelling, headaches, labored breathing and digestive upset.
Food Allergy - Additive
FDA Label NDC 55714-2315
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 Food Allergy - Additive (NDC 55714-2315). 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 pellets by mouth (ages 0 to 11, give 3 pellets) as needed or as directed by a health professional. Under age 2, crush/dissolve pellets in purified water. Sensitive persons begin with 1 pellet and gradually increase to full dose.
Otc - Active Ingredient Section
Allersodes 60x, Allersodes 15x,Histaminum hydrochloricum 15x, Lycopersicum 15x, Saccharinum 15x, Sac. lac. 15x, Solanum tub. 15x, Torula cerevisiae 15x, Ustilago maidis 15x, Aconitum nap. 10x, Antimon.crud. 10x, Arsenicum alb. 10x, Baptisia 10x, Cinchona 10x, Gelsemium 10x, Ipecac. 10x, Lachesis 10x, Ledum 10x, Lycopodium 10x, Nat. mur. 10x, Phos. 10x, Podoph. pelt. 10x, Pulsatilla 10x, Rhus tox. 10x, Sepia 10x, Sulphur 10x, Urtica ur. 10x, Iris vers. 3x, Solidago 3x.
Otc - Purpose Section
Formulated for associated symptoms such as itching, swelling, headaches, labored breathing and digestive upset.
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: 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 (N058 P01)
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