Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED 100 mg Tablets: Appearance: Dark brown to maroon colored, round, film coated tablets debossed "114" on one side and plain on the other side. NDC: 70518-0218-00 NDC: 70518-0218-01 NDC: 70518-0218-02 NDC: 70518-0218-03 PACKAGING: 6 in 1 BOTTLE PLASTIC PACKAGING: 30 in 1 BLISTER PACK PACKAGING: 10 in 1 BOTTLE PLASTIC PACKAGING: 12 in 1 BOTTLE PLASTIC DISPENSE contents with a child-resistant closure (as required) and in a tight container as defined in the USP. STORE at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Disclaimer: This is not an Orange Book Product and has not been subjected to FDA therapeutic equivalency or other equivalency testing. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762; DRUG: Phenazopyridine Hydrochloride GENERIC: Phenazopyridine Hydrochloride DOSAGE: TABLET ADMINSTRATION: ORAL NDC: 70518-0218-0 NDC: 70518-0218-1 NDC: 70518-0218-2 NDC: 70518-0218-3 COLOR: brown SHAPE: ROUND SCORE: No score SIZE: 7 mm IMPRINT: 114 PACKAGING: 6 in 1 BOTTLE PLASTIC PACKAGING: 30 in 1 BLISTER PACK PACKAGING: 10 in 1 BOTTLE PLASTIC PACKAGING: 12 in 1 BOTTLE PLASTIC ACTIVE INGREDIENT(S): PHENAZOPYRIDINE HYDROCHLORIDE 100mg in 1 INACTIVE INGREDIENT(S): HYPROMELLOSE 2910 (15 MPA.S) POLYETHYLENE GLYCOL 400 CROSCARMELLOSE SODIUM MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE STARCH, CORN SILICON DIOXIDE POVIDONE K30 MM1 MM4
- HOW SUPPLIED 100 mg Tablets: Appearance: Dark brown to maroon colored, round, film coated tablets debossed "114" on one side and plain on the other side. NDC: 70518-0218-00 NDC: 70518-0218-01 NDC: 70518-0218-02 NDC: 70518-0218-03 PACKAGING: 6 in 1 BOTTLE PLASTIC PACKAGING: 30 in 1 BLISTER PACK PACKAGING: 10 in 1 BOTTLE PLASTIC PACKAGING: 12 in 1 BOTTLE PLASTIC DISPENSE contents with a child-resistant closure (as required) and in a tight container as defined in the USP. STORE at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Disclaimer: This is not an Orange Book Product and has not been subjected to FDA therapeutic equivalency or other equivalency testing. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762
- DRUG: Phenazopyridine Hydrochloride GENERIC: Phenazopyridine Hydrochloride DOSAGE: TABLET ADMINSTRATION: ORAL NDC: 70518-0218-0 NDC: 70518-0218-1 NDC: 70518-0218-2 NDC: 70518-0218-3 COLOR: brown SHAPE: ROUND SCORE: No score SIZE: 7 mm IMPRINT: 114 PACKAGING: 6 in 1 BOTTLE PLASTIC PACKAGING: 30 in 1 BLISTER PACK PACKAGING: 10 in 1 BOTTLE PLASTIC PACKAGING: 12 in 1 BOTTLE PLASTIC ACTIVE INGREDIENT(S): PHENAZOPYRIDINE HYDROCHLORIDE 100mg in 1 INACTIVE INGREDIENT(S): HYPROMELLOSE 2910 (15 MPA.S) POLYETHYLENE GLYCOL 400 CROSCARMELLOSE SODIUM MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE STARCH, CORN SILICON DIOXIDE POVIDONE K30 MM1 MM4
Overview
Phenazopyridine Hydrochloride is dark brown fine granular powder. It has a specific local analgesic effect in the urinary tract, promptly relieving burning and pain. Phenazopyridine HCl tablets contain the following inactive ingredients: hypromellose, polyethylene glycol, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, pregelatinized starch, maize(corn) starch, silicone dioxide, polyvinylpyrrolidone. image description
Indications & Usage
Phenazopyridine HCl is indicated for the symptomatic relief of pain, burning, urgency, frequency, and other discomforts arising from irritation of the lower urinary tract mucosa caused by infection, trauma, surgery, endoscopic procedures, or the passage of sounds or catheters. The use of Phenazopyridine HCl for relief of symptoms should not delay definitive diagnosis and treatment of causative conditions. Because it provides only symptomatic relief, prompt appropriate treatment of the cause of pain must be instituted and Phenazopyridine HCl should be discontinued when symptoms are controlled. The analgesic action may reduce or eliminate the need for systemic analgesics or narcotics. It is, however, compatible with antibacterial therapy and can help to relieve pain and discomfort during the interval before antibacterial therapy controls the infection. Treatment of a urinary tract infection with Phenazopyridine HCl should not exceed 2 days because there is a lack of evidence that the combined administration of Phenazopyridine HCl and an antibacterial provides greater benefit than administration of the antibacterial alone after 2 days. (See DOSAGE AND ADMINISTRATION section.)
Dosage & Administration
100 mg Tablets: Average adult dosage is two tablets 3 times a day after meals. When used concomitantly with an antibacterial agent for the treatment of a urinary tract infection, the administration of Phenazopyridine HCl should not exceed 2 days. To report SUSPECTED ADVERSE REACTIONS, contact Winder Laboratories, LLC at 1-770-307-0703, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Warnings & Precautions
No warnings available yet.
Contraindications
Phenazopyridine HCl should not be used in patients who have previously exhibited hypersensitivity to it. The use of Phenazopyridine HCl is contraindicated in patients with renal insufficiency.
Adverse Reactions
Headache, rash, pruritus and occasional gastrointestinal disturbance. An anaphylactoid-like reaction has been described. Methemoglobinemia, hemolytic anemia, renal and hepatic toxicity have been reported, usually at overdosage levels (see OVERDOSAGE Section).
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