Yyba (as Pld) - Welmate - Urinary Pain Relief (73581-909)

Yyba (as Pld) - Welmate - Urinary Pain Relief (73581-909)
SPL v7
SPL
SPL Set ID ad034f45-2852-f3c9-e053-2a95a90a38cb
Route
ORAL
Published
Effective Date 2025-01-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenazopyridine (99.5 mg)
Inactive Ingredients
Magnesium Stearate Hypromellose, Unspecified Starch, Corn Polyethylene Glycol 400 Cellulose, Microcrystalline Povidone K30 Croscarmellose Sodium

Identifiers & Packaging

Pill Appearance
Imprint: sp9 Shape: round Color: brown Size: 7 mm Score: 1
Marketing Status
UNAPPROVED DRUG OTHER Active Since 2020-09-10

Description

Active ingredient (in each tablet) Phenazopyridine Hydrochloride 99.5 mg


Medication Information

Warnings and Precautions

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

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 adminitration of phenazopyridine hydrochloride has induced neoplasia in rats (large instestine) andmice (liver). Although no association between phenazopyridine hydrochloride and human enoplasia has beeen reported, adequate epidemiological studies along these lines have not been conducted.

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

Indications and Usage

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

Dosage and Administration

Adults and children 12 years of age and over: 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 wihout consulting a doctor

Description

Active ingredient (in each tablet) Phenazopyridine Hydrochloride 99.5 mg

Section 42229-5

Size and color of tablets may vary.

*This product is not manufactured or distributed by the owner of the registered trademark AZO Urinary Pain Relief®.

Distributed by: Wellspring

Airmont, NY 10952, USA

Section 50565-1

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

Section 51727-6

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

Section 51945-4

Section 53413-1

call toll-free 1-845-547-2667

Section 55105-1

Purpose

Urinary Tract Analgesic

Section 55106-9

Active ingredient (in each tablet)

Phenazopyridine Hydrochloride 99.5 mg

Section 60561-8

■ 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

■ long term administration of phenazopyridine HCI 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 room temperature 15°-30°C (59°-86°F) in a dry place and protect from light


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

Adults and children 12 years of age and over: 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 wihout consulting a doctor

Warnings and Precautions (34071-1)

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

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 adminitration of phenazopyridine hydrochloride has induced neoplasia in rats (large instestine) andmice (liver). Although no association between phenazopyridine hydrochloride and human enoplasia has beeen reported, adequate epidemiological studies along these lines have not been conducted.

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

Section 42229-5 (42229-5)

Size and color of tablets may vary.

*This product is not manufactured or distributed by the owner of the registered trademark AZO Urinary Pain Relief®.

Distributed by: Wellspring

Airmont, NY 10952, USA

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

call toll-free 1-845-547-2667

Section 55105-1 (55105-1)

Purpose

Urinary Tract Analgesic

Section 55106-9 (55106-9)

Active ingredient (in each tablet)

Phenazopyridine Hydrochloride 99.5 mg

Section 60561-8 (60561-8)

■ 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

■ long term administration of phenazopyridine HCI 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 room temperature 15°-30°C (59°-86°F) in a dry place and protect from light


Advanced Ingredient Data


Raw Label Data

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