Active Ingredient (In Each Tablet)
Phenazopyridine Hydrochloride 99.5 mg
Right Remedies Maximum Strength Urinary Pain Relief Tablet
FDA Label NDC 70692-163
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Strive Pharmaceuticals Inc. for the product Right Remedies Maximum Strength Urinary Pain Relief (NDC 70692-163). 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 active ingredient (in each tablet), purpose, use, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Urinary tract analgesic
Use
Relief from urinary pain, burning, urgency and frequency associated with urinary tract infections. Treatment should not exceed 2 days; see Directions
Warnings
Do not exceed recommended dosage
Do not use if you have Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency unless approved by your physician.
Ask a doctor before use if you have • kidney disease • allergies to foods, preservatives or dyes • had a hypersensitive reaction to Phenazopyridine Hydrochloride
When using this product • stomach upset may occur, taking this product with or after meals may reduce stomach upset • your urine will become reddish orange in color. This is not harmful, but care should be taken to avoid staining clothing or other items.
Stop use and ask a doctor if • your symptoms last for more than 2 days • you suspect you are having an adverse reaction to the medication. Long-term administration of Phenazopyridine HCl has induced neoplasia in rats (large intestine) and mice (liver). Although no association between Phenazopyridine HCl and human neoplasia has been reported, adequate epidemiological studies along these lines have not been conducted.
If pregnant or breastfeeding, ask a health professional before use. A pregnancy test and consultation with a health professional if pregnancy is confirmed is recommended prior to use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of an overdose, get medical help or contact a Poison Control Center right away.
Directions
• Adults and children 12 years and over: Take 2 tablets 3 times daily with or after meals as needed for up to two days. Take with a full glass of water. Do not use for more than 2 days (12 tablets) without consulting a doctor • Children under 12 years: Do not use without consulting a doctor
Other Information
• This product can interfere with laboratory tests including urine, glucose (sugar), and ketones tests • This product may stain contact lenses and other items if handled after touching tablets. • Store at room temperature between 20°C -25°C (68°F-77°F) in a dry place and protect from light.
Inactive Ingredients
colloidal silicone dioxide, gum acacia extra pure, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, maize starch, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, sodium starch glycolate.
Questions?
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Packaging
Strive-163 (70692163 4)
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