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NDC 71205-0584-30 Good Neighbor Pharmacy Urinary Pain Relief 95 mg/1 Details

Good Neighbor Pharmacy Urinary Pain Relief 95 mg/1

Good Neighbor Pharmacy Urinary Pain Relief is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Proficient Rx LP. The primary component is PHENAZOPYRIDINE HYDROCHLORIDE.

MedlinePlus Drug Summary

Phenazopyridine relieves urinary tract pain, burning, irritation, and discomfort, as well as urgent and frequent urination caused by urinary tract infections, surgery, injury, or examination procedures. However, phenazopyridine is not an antibiotic; it does not cure infections.

Related Packages: 71205-0584-30
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Phenazopyridine

Product Information

NDC	71205-0584
Product ID	71205-584_1f61dcb1-c108-433a-963c-215cd2239a3e
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Good Neighbor Pharmacy Urinary Pain Relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	PHENAZOPYRIDINE HYDROCHLORIDE
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	95
Active Ingredient Units	mg/1
Substance Name	PHENAZOPYRIDINE HYDROCHLORIDE
Labeler Name	Proficient Rx LP
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	UNAPPROVED DRUG OTHER
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 71205-0584-30 (71205058430)

Pricing Information	N/A
NDC Package Code	71205-584-30
Billing NDC	71205058430
Package	1 BLISTER PACK in 1 CARTON (71205-584-30) / 30 TABLET in 1 BLISTER PACK
Marketing Start Date	2021-06-29
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 9281da67-6e41-43e3-b8af-290657aa80db Details

Active Ingredient

Phenazopyridine Hydrochloride 95 mg

Purpose

Urinary Analgesic

Uses

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

Warning

Do not exceed recommended dosage

Ask Doctor before use if you have

■ kidney disease

■ allergies to foods, preservatives or dyes

■ had a hypersensitive reaction to Phenazopyridine

When using this product

■ 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

If pregnant or breast feeding

ask a health professional before use.

Keep out of the reach of children

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

Directions

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

■ Children under 12: consult a doctor

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

Inactive Ingredients

lactose, magnesium silicate, magnesium stearate, microcrystalline

cellulose, pharmaceutical glaze, and sodium starch glycolate. May also contain: corn starch,

croscarmellose sodium, polyvinylpyrrolidone, pregelatinized starch and silicon dioxide.

Package/Label Principal Display Panel

INGREDIENTS AND APPEARANCE

GOOD NEIGHBOR PHARMACY URINARY PAIN RELIEF

phenazopyridine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71205-584(NDC:46122-337)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PHENAZOPYRIDINE HYDROCHLORIDE (UNII: 0EWG668W17) (PHENAZOPYRIDINE - UNII:K2J09EMJ52)	PHENAZOPYRIDINE HYDROCHLORIDE	95 mg

Ingredient Name	Strength
Inactive Ingredients
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SHELLAC (UNII: 46N107B71O)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
MAGNESIUM SILICATE (UNII: 9B9691B2N9)

Product Characteristics
Color	red	Score	no score
Shape	ROUND	Size	7mm
Flavor		Imprint Code	P95
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71205-584-30	1 in 1 CARTON	06/29/2021
1		30 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Unapproved drug other		07/01/2013

Labeler - Proficient Rx LP (079196022)

Name	Address	ID/FEI	Business Operations
Establishment
Proficient Rx LP		079196022	RELABEL(71205-584) , REPACK(71205-584)

Revised: 9/2022

Document Id: 1f61dcb1-c108-433a-963c-215cd2239a3e

Set id: 9281da67-6e41-43e3-b8af-290657aa80db

Version: 2

Effective Time: 20220901