HEALTHMART MAXIMUM STRENGTH URINARY PAIN RELIEF- phenazopyridine hydrochloride tablet

United States - English - NLM (National Library of Medicine)

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Active ingredient:
PHENAZOPYRIDINE HYDROCHLORIDE (UNII: 0EWG668W17) (PHENAZOPYRIDINE - UNII:K2J09EMJ52)
Available from:
Strategic Sourcing Services LLC
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Urinary Analgesic ■ kidney disease ■ allergies to food, preservatives or dyes ■ had a hypersensitive reaction to phenazopyridine ■ your symptoms last for more than 2 days ■ you suspect you are having an adverse reaction to the medication Fast relief from urinary pain, burning, urgency and frequency associated with urinary tract infections.
Authorization status:
unapproved drug other
Authorization number:
62011-0412-1

HEALTHMART MAXIMUM STRENGTH URINARY PAIN RELIEF- phenazopyridine

hydrochloride tablet

Strategic Sourcing Services LLC

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.

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DRUG FACTS

Active ingredient (in each tablet)

Phenazopyridine Hydrochloride 99.5 mg .

Purpos e

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.

Us e

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

HEALTHMART MAXIMUM STRENGTH URINARY PAIN RELIEF

phenazopyridine hydrochloride tablet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 20 11-0 412

Strategic Sourcing Services LLC

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

PHENAZO PYRIDINE HYDRO CHLO RIDE (UNII: 0 EWG6 6 8 W17) (PHENAZOPYRIDINE -

UNII:K2J0 9 EMJ52)

PHENAZOPYRIDINE

HYDROCHLORIDE

9 9 .5 mg

Inactive Ingredients

Ingredient Name

Stre ng th

LACTO SE (UNII: J2B2A4N9 8 G)

MAGNESIUM SILICATE (UNII: 9 B9 6 9 1B2N9 )

Product Characteristics

Color

bro wn

S core

no sco re

S hap e

OVAL

S iz e

9 mm

Flavor

Imprint Code

p9 9

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 20 11-0 412-1 1 in 1 CARTON

0 9 /12/20 19

1

12 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

unappro ved drug o ther

0 9 /12/20 19

Labeler -

Strategic Sourcing Services LLC (116956644)

Registrant -

Reese Pharmaceutical Co (004172052)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Reese Pharmaceutical Co

0 0 41720 52

relabel(6 20 11-0 412) , repack(6 20 11-0 412)

Revised: 9/2019

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