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  5. Label Information: Phenazopyridine Hydrochloride

FDA Label for Phenazopyridine Hydrochloride

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTC - DO NOT USE
    6. OTC - WHEN USING
    7. OTC - STOP USE
    8. OTC - PREGNANCY OR BREAST FEEDING
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DOSAGE & ADMINISTRATION
    11. INACTIVE INGREDIENT
    12. OTHER
    13. PACKAGING

Phenazopyridine Hydrochloride Product Label

The following document was submitted to the FDA by the labeler of this product Drug Ocean Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Active ingredient (in each tablet)

Phenazopyridine Hydrochloride 95 mg


Otc - Purpose



Purpose

Urinary tract analgesic


Indications & Usage



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


Warnings



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



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


Otc - When Using



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



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



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



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


Dosage & Administration



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



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


Other



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- 028-14

Phenazopyridine Hydrochloride Tablets, 95 mg

Urinary Tract Pain Relief

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

    • 30 Tablets

    Blister Label


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