Indications & Usage Section
Formulated for associated symptoms such as nausea, "spitting up," vomiting, cramping, pain and gas.
Tummy Upset Pellet
FDA Label NDC 55714-1731
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 Tummy Upset (NDC 55714-1731). 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
Children, ages 0 to 11, give 3 pellets by mouth (ages 12 and up, give 6 pellets) as needed or a directed by a health professional. Under age 2, crush/dissolve pellets in purified water. Sensitive person begin with 1 pellet and gradually increase to full dose.
Otc - Active Ingredient Section
Equal parts of Chamomilla 6x, Echinacea 6x, Iris versicolor 6x, Ruta graveolens 6x, Taraxacum officinale 6x, Aloe 15x, Angelica sinensis radix 15x, Antimonium crudum 15x, Argentum nitricum 15x, Arnica montana 15x, Arsenicum album 15x, Baptisia tinctoria 15x, Bismuthum metallicum 15x, Bryonia 15x, Cinchona officinalis 15x, Graphites 15x, Hydrastis canadensis 15x, Ipecacuanha 15x, Lachesis mutus 15x, Lycopodium clavatum 15x, Myrrha 15x, Natrum carbonicum 15x, Nux vomica 15x, Phosphorus 15x, Pulsatilla 15x, Zingiber officinale 15x.
Otc - Purpose Section
Formulated for associated symptoms such as nausea, "spitting up," vomiting, cramping, pain and gas.
Inactive Ingredient Section
Inactive Ingredients: Gluten-free, non-GMO, organic beet-derived sucrose (lactose-free) pellets.
Questions Section
newtonlabs.net - Questions? 800.448.7256
Newton Laboratories, Inc. FDA Est # 1051203 Conyers, GA 30013
Warnings Section
WARNINGS: 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 (F020 P01)
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