Right Remedies

Right Remedies
SPL v1
SPL
SPL Set ID 3fb23c2e-56b7-4f49-b3f1-5e5f07d61d20
Route
ORAL
Published
Effective Date 2023-12-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenazopyridine (99.5 mg)
Inactive Ingredients
Silicon Dioxide Acacia Hypromellose, Unspecified Lactose Monohydrate Magnesium Stearate Starch, Corn Polyethylene Glycol, Unspecified Povidone, Unspecified Propylene Glycol Sodium Starch Glycolate Type A

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2023-12-01

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. Treatment should not exceed 2 days; see Directions

Section 42229-5

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

maximum strength UTI pain reliever available without a prescription

Among our over the counter urinary pain relief products

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

READ AND KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Distributed by: Strive Pharmaceuticals, Inc.

East Brunswick, NJ 08816

Product of India

*This product is not manufactured or distributed by -Health Inc., distributor of AZO® Urinary Pain Relief

WARNING: This product can expose you to Phenazopyridine Hydrochloride, which is known to the state of California to cause cancer. For more information, visit www.P65Warnings.ca.gov

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.

Warnings

Do not exceed recommended dosage

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

Ask a doctor before use if you have  • kidney disease • allergies to foods, preservatives or dyes  • had a hypersensitive reaction to Phenazopyridine Hydrochloride

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 HCl has induced neoplasia in rats (large intestine) and mice (liver). Although no association between Phenazopyridine HCl 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.

Packaging

Directions

Adults and children 12 years 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 doctorChildren under 12 years: Do not use without consulting a doctor

Questions?

1-888-577-8033 Monday-Friday 8am-4pm EST

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 20°C -25°C (68°F-77°F) in a dry place and protect from light.

Inactive Ingredients

colloidal silicone dioxide, gum acacia extra pure, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, maize starch, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, sodium starch glycolate.

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. Treatment should not exceed 2 days; see Directions

Section 42229-5 (42229-5)

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

maximum strength UTI pain reliever available without a prescription

Among our over the counter urinary pain relief products

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

READ AND KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Distributed by: Strive Pharmaceuticals, Inc.

East Brunswick, NJ 08816

Product of India

*This product is not manufactured or distributed by -Health Inc., distributor of AZO® Urinary Pain Relief

WARNING: This product can expose you to Phenazopyridine Hydrochloride, which is known to the state of California to cause cancer. For more information, visit www.P65Warnings.ca.gov

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.

Purpose

Urinary tract analgesic

Warnings

Do not exceed recommended dosage

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

Ask a doctor before use if you have  • kidney disease • allergies to foods, preservatives or dyes  • had a hypersensitive reaction to Phenazopyridine Hydrochloride

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 HCl has induced neoplasia in rats (large intestine) and mice (liver). Although no association between Phenazopyridine HCl 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.

Packaging

Directions

Adults and children 12 years 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 doctorChildren under 12 years: Do not use without consulting a doctor

Questions?

1-888-577-8033 Monday-Friday 8am-4pm EST

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 20°C -25°C (68°F-77°F) in a dry place and protect from light.

Inactive Ingredients (Inactive ingredients)

colloidal silicone dioxide, gum acacia extra pure, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, maize starch, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, sodium starch glycolate.

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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