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PHENAZOPYRIDINE HYDROCHLORIDE TABLETS


OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)

Phenazopyridine Hydrochloride 99.5 mg


OTC - PURPOSE SECTION

Purpose

Urinary tract analgesic


INDICATIONS & USAGE SECTION

UseRelief from urinary pain, burning, urgency and frequency associated with urinary tract infections.


WARNINGS SECTION

Warnings

Ask a doctor before use if you have

  • kidney disease
  • allergies to foods, preservatives or dyes
  • had a hypersensitive reaction to Phenazopyridine Hydrochloride

OTC - DO NOT USE SECTION

Do not useif you have Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency unless approved by your physician.


OTC - WHEN USING SECTION

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.

OTC - STOP USE SECTION

Stop use and ask doctor if

  • your symptoms last for more than 2 days
  • you suspect you are having an adverse reaction to the medication.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding,ask a healthcare professional before use. A pregnancy test and consultation with a healthcare professional if pregnancy is confirmed is recommended prior to use. 


OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.In case of an overdose, get medical help or contact a Poison Control Center right away.


DOSAGE & ADMINISTRATION SECTION

Directions

  • Adults and children 12 years and older: Take 2 tablets 3 times daily with or after meals as needed for up to two days. Take with a full glass of water. Do not use for more than 2 days (12 tablets) without consulting a doctor. 
  • Children under 12: Do not use without consulting a doctor.

INACTIVE INGREDIENT SECTION

Inactive ingredients  carnauba wax, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized corn starch. May also contain corn starch.


Other Information

Tamper evident:Product is sealed within blisters. Do not use if any part of the blister is torn, open or damaged.

  • This product contains Phenazopyridine Hydrochloride, known to the State of California to cause cancer
  • 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 o-86 oF) in a dry place and protect from light.

SPL UNCLASSIFIED SECTION

Questions or comments? Call 1-844-200-6566

Distributed by: Drug Ocean LLC 1 Bridge Plaza, North Central Road, 6th Floor, Suite 675, Fort Lee, NJ 07024

Made in India

Mfg License Code: RA/Drug/RAJ.-1750

ORG 03/2024


Packaging

Drug Ocean NDC 70985- 029-09

Phenazopyridine Hydrochloride Tablets, 99.5 mg

Urinary Tract Pain Relief

12 Tablets

Blister Label

  • Relieves Pain, Burning and Urgency
  • Targets the source of Pain

Packaging

Drug Ocean NDC 70985- 029-13

Phenazopyridine Hydrochloride Tablets, 99.5 mg

Urinary Tract Pain Relief

24 Tablets

Blister Label

  • Relieves Pain, Burning and Urgency
  • Targets the source of Pain