Signature Care Maximum Strength Urinary Pain Relief: Package Insert and Label Information

SIGNATURE CARE MAXIMUM STRENGTH URINARY PAIN RELIEF- phenazopyridine hydrochloride tablet
Safeway

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Active ingredient (in each tablet)

Phenazopyridine Hydrochloride 99.5 mg .

Purpose

Urinary Analgesic

Warnings

Do not exceed recommended dosage

Ask doctor before use if you have

■ kidney disease
■ allergies to food, preservatives or dyes
■ had a hypersensitive reaction to phenazopyridine

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 doctor if

■ your symptoms last for more than 2 days
■ you suspect you are having an adverse reaction to the medication

If pregnant or breast feeding,

Ask a health professional before use.

Keep out of reach of children

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

Use

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

Inactive ingredients

Lactose, magnesium silicate, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, and sodium starch glycolate.

Directions


■ adults and children 12 years and over:
take 2 tablets 3 times daily with a full glass of water, with or after meals as needed

■ children under 12 years: consult a doctor

■ Do not use for more than 2 days (12 tablets) without consulting a doctor

image of carton
(click image for full-size original)

SIGNATURE CARE MAXIMUM STRENGTH URINARY PAIN RELIEF phenazopyridine hydrochloride tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-792
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) PHENAZOPYRIDINE HYDROCHLORIDE 99.5 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE
MAGNESIUM SILICATE
Product Characteristics
Color brown Score no score
Shape OVAL Size 9mm
Flavor Imprint Code p99
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:21130-792-24 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 24 TABLET in 1 BLISTER PACK This package is contained within the CARTON (21130-792-24)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 12/23/2019
Labeler — Safeway (009137209)
Registrant — Reese Pharmaceutical Co (004172052)
Establishment
Name Address ID/FEI Operations
Reese Pharmaceutical Co 004172052 relabel (21130-792), repack (21130-792)

Revised: 09/2021 Safeway

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