Label: PREFERRED MAXIMUM STRENGTH URINARY PAIN RELIEF- phenazopyridine hydrochloride tablet
- NDC Code(s): 68788-7778-1
- Packager: Preferred Pharmaceuticals Inc.
- This is a repackaged label.
- Source NDC Code(s): 10956-210
- 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 July 26, 2023
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- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Warnings
- Ask doctor before use if you have
- When using this product
- Stop use and ask doctor if
- If pregnant or breast feeding,
- Keep out of reach of children
- Use
- Inactive ingredients
- Directions
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
PREFERRED MAXIMUM STRENGTH URINARY PAIN RELIEF
phenazopyridine hydrochloride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68788-7778(NDC:10956-210) 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 LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G) MAGNESIUM SILICATE (UNII: 9B9691B2N9) Product Characteristics Color brown Score no score Shape OVAL Size 9mm Flavor Imprint Code p99 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68788-7778-1 12 in 1 BLISTER PACK; Type 0: Not a Combination Product 09/09/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 09/09/2020 Labeler - Preferred Pharmaceuticals Inc. (791119022) Registrant - Preferred Pharmaceuticals Inc. (791119022) Establishment Name Address ID/FEI Business Operations Preferred Pharmaceuticals Inc. 791119022 RELABEL(68788-7778)