OTC Medication Information: UristatUTI Relief Pak UTI Relief Pak

URISTATUTI RELIEF PAK UTI RELIEF PAK- phenazopyridine hydrochloride tablet
Liberty Pharmaceuticals, Inc.

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 Facts

Active ingredient

(in each tablet )

Phenazopyridine hydrochloride 95mg

Purpose

Urinary analgesic

Use

fast relief from urinary pain, burning, urgency and frequency associated with urinary tract infections

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.

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 breast-feeding,

ask a health care professional before use.

Keep out of reach of children.

In case of an overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

  • Adults and children 12 years of age and over: take 2 tablets 3 times daily with a full glass of water, with or after meals as needed.
  • Children under 12 years of age: consult a doctor.
    Do not use for more than 2 days (12 tablets) without consulting a doctor

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.

Inactive ingredients

corn starch, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, polyvinylpyrrolidone, pregelatinized starch, silicon dioxide, and talc

Questions?

Call 1-800-344-7239 or visit our website at www.Uristat.com

©2015 Distributed by:
Insight Pharmaceuticals LLC
Tarrytown, NY 10591
A Prestige Brands Company

Repackaged By:

Aidarex Pharmaceuticals, LLC.

Corona, CA 92882

PRINCIPAL DISPLAY PANEL

Phenazopyridine Hydrochloride 95mg

IMAGE LABEL
(click image for full-size original)
URISTATUTI RELIEF PAK UTI RELIEF PAK
phenazopyridine hydrochloride tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0440-8065(NDC:63736-961)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) PHENAZOPYRIDINE HYDROCHLORIDE 95 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SHELLAC
Product Characteristics
Color BROWN Score no score
Shape ROUND Size 7mm
Flavor Imprint Code U
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0440-8065-01 100 TABLET in 1 BOTTLE None
2 NDC:0440-8065-05 500 TABLET in 1 BOTTLE None
3 NDC:0440-8065-30 30 TABLET in 1 BOTTLE None
4 NDC:0440-8065-69 96 TABLET in 1 BLISTER PACK None
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)

Revised: 10/2016 Liberty Pharmaceuticals, Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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