Indications & Usage Section
Incontinence Formulated for symptoms associated with various types of incontinence such as stress incontinence, urge incontinence and overflow incontinence.
Incontinence
FDA Label NDC 55714-4535
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 Incontinence (NDC 55714-4535). 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, active ingredient section, purpose section, inactive ingredient section, questions? section, warnings section, 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
Directions: Ages 12 and up, take 6 pellets orally (ages 0 to 11, give 3 pellets) one to four times daily or as directed by a healthcare professional. Under age 2, crush or dissolve pellets in purified water.
Active Ingredient Section
Aloe 20x, Arg. nit. 20x, Arsenicum alb. 20x, Belladonna 20x, Benzoicum acidum 20x, Bryonia 20x, Cantharis 20x, Causticum 20x, Equisetum hyemale 20x, Ferrum metallicum 20x, Gelsemium 20x, Ignatia 20x, Kali phos. 20x, Lycopodium 20x, Nat. mur. 20x, Nitricum ac. 20x, Plantago 20x, Pulsatilla 20x, Rhus aromatica 20x, Sabal 20x, Secale 20x, Sepia 20x, Staphysag. 20x, Stramonium 20x, Thyroidinum 20x, Verbascum 20x, Echinacea 8x, Hydrastis 8x, Echinacea 3x, Hydrastis 3x.
Purpose Section
Formulated for symptoms associated with various types of incontinence such as stress incontinence, urge incontinence and overflow incontinence.
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: 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.
Pregnancy Or Breast Feeding Section
Consult a licensed healthcare professional if pregnant or nursing or if symptoms worsen or persist for more than a few days.
Keep Out Of Reach Of Children Section
Keep out of reach of children.
Package Label
Package Label (R068 P01)
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