Tummy Upset
FDA Label NDC 55714-1508

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 55714-1508). 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

Indications & Usage Section

Tummy Upset  Formulated for symptoms associated with digestive discomfort such as nausea, "spitting up", vomiting, cramping, pain and gas.

Dosage & Administration Section

ORAL USE ONLY - SHAKE WELL.  Children, ages 0 to 11, give 3 drops orally (ages 12 and up, give 6 drops) as needed or as directed by a healthcare professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

Otc - Active Ingredient Section

Bismuthum metallicum 15x, Aloe 10x, Angelica sinensis radix 10x, Antimon. crud. 10x, Arg. nit. 10x, Arnica 10x, Arsenicum alb. 10x, Baptisia 10x, Bryonia 10x, Cinchona 10x, Graphites 10x, Hydrastis 10x, Ipecac. 10x, Lachesis 10x, Lycopodium 10x, Myrrha 10x, Nat. carb. 10x, Nux vom. 10x, Phosphorus 10x, Pulsatilla 10x, Zingiber 10x, Chamomilla 3x, Echinacea 3x, Iris versicolor 3x, Ruta 3x, Taraxacum 3x.

Otc - Purpose Section

Formulated for symptoms associated with digestive discomfort such as nausea,"spitting up", vomiting, cramping, pain and gas.

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: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children.  

Otc - Pregnancy Or Breast Feeding Section

Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. 

Otc - Keep Out Of Reach Of Children Section

Keep out of reach of children.

Package Label

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