Label: URISTATUTI RELIEF PAK UTI RELIEF PAK- phenazopyridine hydrochloride tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 0440-8065-01, 0440-8065-05, 0440-8065-30, 0440-8065-69 - Packager: Liberty Pharmaceuticals, Inc.
- This is a repackaged label.
- Source NDC Code(s): 63736-961
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated October 12, 2016
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Use
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Warnings
Do not exceed recommended dosage
Ask a doctor before use if you have
- Kidney disease
- Allergies to foods, preservatives, or dyes
- Had a hypersensitive reaction to phenazopyridine
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.
- Kidney disease
- Directions
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Other information
- This product may stain contact lenses
- This product can interfere with laboratory tests including urine, glucose (sugar), and ketones test
- Long term administration of phenazopyridine HCl has induced neoplasia in rats (large intestine) and mice (liver). Although no association between phenazopyridine hydrochloride and human neoplasia has been reported, adequate epidemiological studies along these lines have not been conducted
- Store at 20º-25º C (68º-77º F) in a dry place and protect from light.
- This product may stain contact lenses
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
URISTATUTI RELIEF PAK UTI RELIEF PAK
phenazopyridine hydrochloride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0440-8065(NDC:63736-961) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENAZOPYRIDINE HYDROCHLORIDE (UNII: 0EWG668W17) (PHENAZOPYRIDINE - UNII:K2J09EMJ52) PHENAZOPYRIDINE HYDROCHLORIDE 95 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SHELLAC (UNII: 46N107B71O) Product Characteristics Color BROWN Score no score Shape ROUND Size 7mm Flavor Imprint Code U Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0440-8065-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 04/29/2015 2 NDC:0440-8065-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 04/29/2015 3 NDC:0440-8065-30 30 in 1 BOTTLE; Type 0: Not a Combination Product 04/29/2015 4 NDC:0440-8065-69 96 in 1 BLISTER PACK; Type 0: Not a Combination Product 04/29/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 04/29/2015 Labeler - Liberty Pharmaceuticals, Inc. (012568840)
