Allergies
FDA Label NDC 55714-1706

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 Allergies (NDC 55714-1706). 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

Allergies  Formulated for symptoms associated with food and environmental allergens such as congestion, swollen glands, runny nose, cough, rashes and stomach upset.

Dosage & Administration Section

Directions:  Children, ages 0 to 11, give 3 pellets by mouth (ages 12 and up, give 6 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, Xerophyllum asphodeloides 30x, Aethusa cynapium 15x, Alfalfa 15x, Allersodes 15x, Ambrosia artemisiaefolia 15x, Arsenicum alb. 15x, Bromium 15x, Bryonia 15x, Calc. Carb. 15x, Chamomilla 15x, Chelidonium majus 15x, Euphrasia 15x, Gelsemium 15x, Histaminum hydrochloricum 15x, Juniperus virginiana 15x, Kali iod. 15x, Lycopersicum esculentum 15x, Lycopodium 15x, Nat. mur. 15x, Pulsatilla 15x, Rhus toxicodendron 15x, Sabadilla 15x, Saccharinum 15x, Sac lac. 15x, Solanum tuberosum 15x, Sulphur 15x, Torula cerevisiae 15x, Apis mel. 3x, Echinacea 3x, Hydrastis 3x, Taraxacum 3x.

Otc - Purpose Section

Formulated for symptoms associated with food and environmental allergens such as congestion, swollen glands, runny nose, cough, rashes and stomach 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 (F007 P01)

Package Label (F007 P01)

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