Maximum Strength Urinary Pain Relief

Maximum Strength Urinary Pain Relief
SPL v1
SPL
SPL Set ID a10464cf-36b2-460f-b31c-2e0edee3e4cf
Route
ORAL
Published
Effective Date 2024-06-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenazopyridine (99.5 mg)
Inactive Ingredients
Starch, Corn Microcrystalline Cellulose Povidone Croscarmellose Sodium Magnesium Stearate Silicon Dioxide Hypromellose, Unspecified Polyethylene Glycol, Unspecified

Identifiers & Packaging

Pill Appearance
Imprint: SP9 Shape: round Color: brown Size: 7 mm Score: 1
Marketing Status
UNAPPROVED DRUG OTHER Active Since 2024-05-01

Description

Phenazopyridine Hydrochloride 99.5 mg 

Purpose

Urinary tract analgesic


Medication Information

Purpose

Urinary tract analgesic

Description

Phenazopyridine Hydrochloride 99.5 mg 

Use

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

Section 50565-1

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

Section 51945-4

Compare to the active ingredient in  AZO Urinary Pain Relief ®Maximum Strength*  

NDC 80513-517-72

Maximum Strength Urinary Pain Relief

99.5 mg Phenazopyridine Hydrochloride

#1 DOCTOR RECOMMENDED OTC INGREDIENT FOR UTI PAIN

TEMPORARY RELIEF OF URINARY PAIN, BURNING & URGENCY

Urinary Analgesic

72 Tablets

DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED

Size and color of tablet may very.

WARNING: This product can expose you to chemicals including phenazopyridine hydrochloride, which is known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov.

*This product is not manufactured or distributed by I-Health, Inc., owner of the registered trademark of AZO Urinary Pain Relief ®Maximum Strength

Distributed by:

ADVANCED RX LLC,

1942 NE 163rd St North Miami Beach,

FL 33162 U.S.A.

MADE IN USA

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 Hydrochloride

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

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.

• Long-term administration of phenazopyridine hydrochloride 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.

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

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 years:Do not use without consulting a doctor

Drug Facts

Questions?

call toll-free 1-800-630-8895

Other Information

• This product can interfere with laboratory tests including urine, glucose (sugar), and ketones tests

• This product may stain contact lenses and other items if handled after touching tablets.

• Store at room temperature between (59ºF -86ºF) in a dry place and protect from light.

Inactive Ingredients

pregelatinized starch, microcrystalline cellulose, maize (corn) strach, povidone, croscarmellose sodium, magnesium stearate, colloidal silicone dioxide, hydroxypropyl methylcellulose, polyethylene glycol.

Active Ingredient (in Each Tablet)

Phenazopyridine Hydrochloride 99.5 mg 


Structured Label Content

Use

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

Section 50565-1 (50565-1)

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

Section 51945-4 (51945-4)

Compare to the active ingredient in  AZO Urinary Pain Relief ®Maximum Strength*  

NDC 80513-517-72

Maximum Strength Urinary Pain Relief

99.5 mg Phenazopyridine Hydrochloride

#1 DOCTOR RECOMMENDED OTC INGREDIENT FOR UTI PAIN

TEMPORARY RELIEF OF URINARY PAIN, BURNING & URGENCY

Urinary Analgesic

72 Tablets

DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED

Size and color of tablet may very.

WARNING: This product can expose you to chemicals including phenazopyridine hydrochloride, which is known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov.

*This product is not manufactured or distributed by I-Health, Inc., owner of the registered trademark of AZO Urinary Pain Relief ®Maximum Strength

Distributed by:

ADVANCED RX LLC,

1942 NE 163rd St North Miami Beach,

FL 33162 U.S.A.

MADE IN USA

Purpose

Urinary tract analgesic

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 Hydrochloride

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

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.

• Long-term administration of phenazopyridine hydrochloride 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.

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

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 years:Do not use without consulting a doctor

Drug Facts

Questions?

call toll-free 1-800-630-8895

Other Information (Other information)

• This product can interfere with laboratory tests including urine, glucose (sugar), and ketones tests

• This product may stain contact lenses and other items if handled after touching tablets.

• Store at room temperature between (59ºF -86ºF) in a dry place and protect from light.

Inactive Ingredients (Inactive ingredients)

pregelatinized starch, microcrystalline cellulose, maize (corn) strach, povidone, croscarmellose sodium, magnesium stearate, colloidal silicone dioxide, hydroxypropyl methylcellulose, polyethylene glycol.

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Phenazopyridine Hydrochloride 99.5 mg 


Advanced Ingredient Data


Raw Label Data

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