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NDC 49973-0301-31 AZO 95 mg/1 Details
AZO 95 mg/1
AZO is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by i-Health, Inc.. The primary component is PHENAZOPYRIDINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Phenazopyridine relieves urinary tract pain, burning, irritation, and discomfort, as well as urgent and frequent urination caused by urinary tract infections, surgery, injury, or examination procedures. However, phenazopyridine is not an antibiotic; it does not cure infections.
Related Packages: 49973-0301-31Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenazopyridine
Product Information
NDC | 49973-0301 |
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Product ID | 49973-301_9ff96c23-b19f-4664-abb3-359fb901d19b |
Associated GPIs | |
GCN Sequence Number | n/a |
GCN Sequence Number Description | n/a |
HIC3 | n/a |
HIC3 Description | n/a |
GCN | n/a |
HICL Sequence Number | n/a |
HICL Sequence Number Description | n/a |
Brand/Generic | n/a |
Proprietary Name | AZO |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Urinary Pain Relief |
Product Type | HUMAN OTC DRUG |
Dosage Form | TABLET |
Route | ORAL |
Active Ingredient Strength | 95 |
Active Ingredient Units | mg/1 |
Substance Name | PHENAZOPYRIDINE HYDROCHLORIDE |
Labeler Name | i-Health, Inc. |
Pharmaceutical Class | n/a |
DEA Schedule | n/a |
Marketing Category | UNAPPROVED DRUG OTHER |
Application Number | n/a |
Listing Certified Through | 2024-12-31 |
Package
Package Images


NDC 49973-0301-31 (49973030131)
NDC Package Code | 49973-301-31 |
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Billing NDC | 49973030131 |
Package | 15 BLISTER PACK in 1 BOX (49973-301-31) / 2 TABLET in 1 BLISTER PACK |
Marketing Start Date | 2012-05-24 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 3d0298b7-eaec-488b-9cab-19af4614ff53 Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Warnings Please read insert for important precautions.
Ask a doctor before use if you have
- kidney disease
- allergies to foods, preservatives or dyes
- had a hypersensitive reaction to Phenazopyridine Hydrochloride.
Caution: Do not use this product if you have Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency unless approved by your physician.
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Other Information
- 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 (59-86 F) in a dry place and protect from light
- Tamper evident: tablets sealed in blisters. Do not use if blister foil or seal is open or damaged.
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
AZO
urinary pain relief tablet |
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Labeler - i-Health, Inc. (061427694) |
Revised: 12/2020
Document Id: 9ff96c23-b19f-4664-abb3-359fb901d19b
Set id: 3d0298b7-eaec-488b-9cab-19af4614ff53
Version: 7
Effective Time: 20201212