Label: AZO- urinary pain relief tablet
- NDC Code(s): 49973-301-30, 49973-301-31, 49973-301-32
- Packager: i-Health, Inc.
- Category: HUMAN OTC DRUG LABEL
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Updated December 12, 2020
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- Drug Facts
- INDICATIONS & USAGE
Warnings Please read insert for important precautions.
Ask a doctor before use if you have
- kidney disease
- allergies to foods, preservatives or dyes
- had a hypersensitive reaction to Phenazopyridine Hydrochloride.
Caution: Do not use this product if you have Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency unless approved by your physician.
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.
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- This product can interfere with laboratory tests including urine, glucose (sugar), and ketones tests
- This product may stain soft contact lenses and other items if handled after touching tablets
- Store at room temperature (59-86 F) in a dry place and protect from light
- Tamper evident: tablets sealed in blisters. Do not use if blister foil or seal is open or damaged.
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
urinary pain relief tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49973-301 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 CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) STARCH, CORN (UNII: O8232NY3SJ) HYPROMELLOSES (UNII: 3NXW29V3WO) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) CARNAUBA WAX (UNII: R12CBM0EIZ) MAGNESIUM STEARATE (UNII: 70097M6I30) Product Characteristics Color brown (Maroon) Score no score Shape ROUND (Tablet) Size 7mm Flavor Imprint Code W Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49973-301-31 15 in 1 BOX 05/24/2012 1 2 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:49973-301-30 15 in 1 BOX 05/24/2012 12/01/2020 2 2 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:49973-301-32 1 in 1 BOX 11/11/2017 11/30/2020 3 18 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 05/24/2012 Labeler - i-Health, Inc. (061427694)