The following Structured Product Label (SPL) was submitted to the FDA by Newton Laboratories, Inc. for the product Bowel - Digestive Care (NDC 55714-2548). 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 dosage & administration section, indications & usage section, otc - keep out of reach of children section, otc - pregnancy or breast feeding section, warnings section, questions section, inactive ingredient section, otc - purpose section, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) 15 minutes before meals or as needed or as directed by a health professional. Sensitive persons begin with 1 drop and gradually increase to full dose.
Formulated for associated symptoms such as vomiting, burning, bloating, gas, nausea, cramping and pressure.
Keep out of reach of children.
If pregnant or breast feeding, ask a doctor before use.
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.
newtonlabs.net - Questions? 800 448-7256
Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013
Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane alcohol 20%.
Formulated for associated symptoms such as vomiting, burning, bloating, gas, nausea, cramping and pressure.
Equal parts of Echinacea 6x, Juglans reg. 6x, Antimon.crud. 15x, Arg. nit. 15x, Arsenicum alb. 15x, Baptisia 15x, Bismuth. met. 15x, Bryonia 15x, Chamomilla 15x, Cinchona 15x, Iris vers. 15x, Kali bic. 15x, Lachesis 15x, Lycopodium 15x, Mag. carb. 15x, Nux vom. 15x, Phos. 15x, Podoph. pelt. 15x, Pulsatilla 15x, Raphanus 15x, Rhus tox. 15x, Tabacum 15x, Verbascum 15x, Zingiber 15x.
Package Label (N029 L01)
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