Label: GOOD REMEDIES MAXIMUM STRENGTH URINARY PAIN RELIEF CAPLET- phenazopyridine hydrochloride tablet, film coated
- NDC Code(s): 70692-178-08
- Packager: Strive Pharmaceuticals Inc.
- 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 January 6, 2025
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient (in each tablet)
- Purpose
- Use
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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 • liver or kidney disease
• allergies to foods, preservatives or dyes • had a 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 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.
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.
- Directions
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Other information
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.
• 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
- Questions or comments?
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SPL UNCLASSIFIED SECTION
Compare to the active ingredient in AZO Urinary Pain Relief® Maximum Strength*
Maximum strength UTI pain reliever available without a prescription†
Helps provide relief for:urinary pain and burning
†Among our over the counter urinary pain relief products
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.
READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION
Distributed by: Strive Pharmaceuticals, Inc.
East Brunswick, NJ 08816PRODUCT OF INDIA
*This product is not manufactured or distributed by i-Health Inc., distributor of AZO Urinary Pain Relief®.
WARNING: This product can expose you to Phenazopyridine Hydrochloride, which is known to the state of California to cause cancer. For more information, visit www.p65warnings.ca.gov
- Packaging
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INGREDIENTS AND APPEARANCE
GOOD REMEDIES MAXIMUM STRENGTH URINARY PAIN RELIEF CAPLET
phenazopyridine hydrochloride tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70692-178 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENAZOPYRIDINE HYDROCHLORIDE (UNII: 0EWG668W17) (PHENAZOPYRIDINE - UNII:K2J09EMJ52) PHENAZOPYRIDINE HYDROCHLORIDE 99.5 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ACACIA (UNII: 5C5403N26O) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) STARCH, CORN (UNII: O8232NY3SJ) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D) Product Characteristics Color brown Score no score Shape capsule Size 9mm Flavor Imprint Code S160 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70692-178-08 1 in 1 CARTON 01/06/2025 1 8 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 01/06/2025 Labeler - Strive Pharmaceuticals Inc. (080028013)
