Otc - Keep Out Of Reach Of Children Section
Keep out of reach of children.
Bladder - Kidney Pellet
FDA Label NDC 55714-2389
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 Bladder - Kidney (NDC 55714-2389). 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 otc - keep out of reach of children section, otc - pregnancy or breast feeding section, warnings section, questions section, inactive ingredient section, otc - purpose section, otc - active ingredient section, dosage & administration section, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Pregnancy Or Breast Feeding Section
If pregnant or breast-feeding, ask a doctor before use.
Warnings Section
Warning:Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms persist for more than a few day, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.
Questions Section
newtonlabs.net ~ Questions? 800.448.7256
Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013
Inactive Ingredient Section
Inactive Ingredients: Gluten-free, non-GMO, organic beet-derived sucrose (lactose free) pellets.
Otc - Purpose Section
Formulated for associated symptoms such as frequent or difficult urination, burning, pain, urgency and the sensation of a full bladder.
Otc - Active Ingredient Section
Equal parts of Echinacea 6x, Hydrastis 6x, Lappa 6x, Solidago 6x, Apis mel. 15x, Berber. vulg. 15x, Bryonia 15x, Cantharis 15x, Cinchona 15x, Equisetum hyem. 15x, Ferrum phos. 15x, Gelsemium 15x, Juniperus com. 15x, Pareira 15x, Phos. 15x, Plantago 15x, Pulsatilla 15x, Sabal 15x, Terebinthina 15x, Uva-ursi 15x.
Dosage & Administration Section
Directions: Ages 12 and up, take 6 pellets by mouth (ages 0 to 11, give 3 pellets) one to four times daily 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.
Indications & Usage Section
Bladder - Kidney Formulated for associated symptoms such as frequent or difficult urination, burning, pain, urgency and the sensation of a full bladder.
Package Label
Package Label (N010 P01)
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