Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 2d3fcf6d-5965-425c-896b-a3b895e4fd44
Route
ORAL
Published
Effective Date 2011-01-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenazopyridine (97.5 mg)
Inactive Ingredients
Lactose Magnesium Silicate

Identifiers & Packaging

Pill Appearance
Imprint: 975 Shape: round Color: red Size: 7 mm Score: 1
Marketing Status
UNAPPROVED DRUG OTHER Active Since 2011-02-01

Description

 PHENAZOPYRIDINE HYDROCHLORIDE   97.5 MG

Purpose

URINARY ANALGESIC


Medication Information

Purpose

URINARY ANALGESIC

Description

 PHENAZOPYRIDINE HYDROCHLORIDE   97.5 MG

Section 51945-4

Warnings

DO NOT EXCEED RECOMMENDED DOSAGE

Stop Use Section

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

Active Ingredient

 PHENAZOPYRIDINE HYDROCHLORIDE   97.5 MG

Ask Doctor Section

ASK DOCTOR BEFORE USE

IF YOU HAVE KIDNEY DISEASE

ALLERGIES TO FOODS,PRESERVATIVES OR DYES

HAD A HYPERSENSITIVE REACTION TO PHENAZOPYRIDINE

When Using Section

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.

Inactive Ingredient

Lactose, magnesium silicate, magnesium stearate, microcrystalline cellulose,

pharmaceutical glaze, and sodium starch glycolate.

Indications & Usage

 Use; fast relief from urinary pain,burning,urgency and frequency associated with urinary tract infections.

Dosage & Administration

Adults and Children 12 years of age and over; take 2 tablets 3 times daily with a full glass of water,with or after meals as needed.

Children under 12 years of age; consult a doctor.

Do not use for more than 2 days ( 12 tablets ) without consulting a Doctor.

Pregnancy Or Breast Feeding

ASK A HEALTH PROFESSIONAL BEFORE USE

Keep Out of Reach of Children

IN CASE OF OVERDOSE ,GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.


Structured Label Content

Section 51945-4 (51945-4)

Purpose (PURPOSE)

URINARY ANALGESIC

Warnings (WARNINGS)

DO NOT EXCEED RECOMMENDED DOSAGE

Stop Use Section (STOP USE SECTION)

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

Active Ingredient (ACTIVE INGREDIENT)

 PHENAZOPYRIDINE HYDROCHLORIDE   97.5 MG

Ask Doctor Section (ASK DOCTOR SECTION)

ASK DOCTOR BEFORE USE

IF YOU HAVE KIDNEY DISEASE

ALLERGIES TO FOODS,PRESERVATIVES OR DYES

HAD A HYPERSENSITIVE REACTION TO PHENAZOPYRIDINE

When Using Section (WHEN USING SECTION)

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.

Inactive Ingredient (INACTIVE INGREDIENT)

Lactose, magnesium silicate, magnesium stearate, microcrystalline cellulose,

pharmaceutical glaze, and sodium starch glycolate.

Indications & Usage (INDICATIONS & USAGE)

 Use; fast relief from urinary pain,burning,urgency and frequency associated with urinary tract infections.

Dosage & Administration (DOSAGE & ADMINISTRATION)

Adults and Children 12 years of age and over; take 2 tablets 3 times daily with a full glass of water,with or after meals as needed.

Children under 12 years of age; consult a doctor.

Do not use for more than 2 days ( 12 tablets ) without consulting a Doctor.

Pregnancy Or Breast Feeding (PREGNANCY OR BREAST FEEDING)

ASK A HEALTH PROFESSIONAL BEFORE USE

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

IN CASE OF OVERDOSE ,GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.


Advanced Ingredient Data


Raw Label Data

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