DOSAGE & ADMINISTRATION SECTION.
Directions. Adults and children 12 years and over: Take tablets times daily with or after meals as needed for up to two days. Take with full glass of water. Do not use for more than days (12 tablets) without consulting doctor Children under 12 years: Do not use without consulting doctor.
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INACTIVE INGREDIENT SECTION.
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.
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INDICATIONS & USAGE SECTION.
Use. Relief from urinary pain, burning, urgency and frequency associated with urinary tract infections. Treatment should not exceed days; see Directions.
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OTC - ACTIVE INGREDIENT SECTION.
Active ingredient (in each tablet). Phenazopyridine Hydrochloride 99.5 mg.
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OTC - KEEP OUT OF REACH OF CHILDREN SECTION.
Keep out of reach of children. In case of an overdose, get medical help or contact Poison Control Center right away.
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OTC - PURPOSE SECTION.
Purpose. Urinary tract analgesic.
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OTC - QUESTIONS SECTION.
Questions. 1-800-910-6874.
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
Packaging. TargetCorp1.
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SPL UNCLASSIFIED SECTION.
Drug Facts.
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STORAGE AND HANDLING SECTION.
Other information. This product can interfere with laboratory tests including urine, glucose (sugar), and ketones tests This product may stain contact lenses and other texts if handled after touching tablets. Store at room temperature between 20oC -25oC (68oF -77oF) in dry place and protect from light.
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WARNINGS SECTION.
Warnings. Do not exceed recommended dosageDo not use if you have Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency unless approved by your physician.Ask doctor before use if you have kidney diseaseo allergies to foods, preservatives or dyes had hypersensitive reaction to Phenazopyridine HydrochlorideWhen 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 texts.Stop use and ask doctor if your symptoms last for more than 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 health professional before use. pregnancy test and consultation with health professional if pregnancy is confirmed is recommended prior to use. Keep out of reach of children. In case of an overdose, get medical help or contact Poison Control Center right away.
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