Urinary Pain Relief by Strategic Sourcing Services LLC DRUG FACTS

Urinary Pain Relief by

Drug Labeling and Warnings

Urinary Pain Relief by is a Otc medication manufactured, distributed, or labeled by Strategic Sourcing Services LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 95 mg

Purpose

Urinary analgesic

Uses

for temporary relief of

• urinary pain
• burning
• urgency
• frequency associated with urinary tract infection

Warnings

Do not use

for more than 2 days without consulting a doctor.

Ask a doctor before use if you have

• kidney disease
• hepatic or renal problems
• allergies to foods, preservatives, or dyes
• previously exhibited hypersensitivity to Phenazopyridine.

Stop use and ask a doctor if

• symptoms persists for more than 2 days
• yellowish tinge of skin or sclera occurs

When using this product

• stomach upset may occur
• a harmless reddish- orange color will be produced in the urine and may stain fabric
• staining of the contact lenses may also occur

If pregnant or breast- feeding

Ask a health care professional before use.

Keep out of reach of children.

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

Directions

• adults and children 12 years of age and over: take 2 tablets 3 times per day with or after meals as needed. Take with a full glass of water.
• children under 12 years of age: consult a doctor

Other information

• store at controlled room temperature 15°-30°C (59°-86°F)
• do not use if cellophane packet is torn or open
• *This product is not manufactured or distributed by Amerifit Brands, Inc., the distributor of AZO Standard®.

Inactive ingredients

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

Principal Display Panel

Compare to AZO STANDARD® active ingredient*

Urinary Pain Relief

Phenazopyridine HCl

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Phenazopyridine Hydrochloride 95 mg

URINARY PAIN RELIEF 
phenazopyridine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49348-364
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
MAGNESIUM SILICATE (UNII: 9B9691B2N9)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SHELLAC (UNII: 46N107B71O)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)

Product Characteristics
Color	RED	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	CPC64
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49348-364-44	1 in 1 CARTON	07/09/2010	12/31/2019
1		30 in 1 CELLO PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		07/09/2010	12/31/2019

Labeler - Strategic Sourcing Services LLC (116956644)

Revised: 9/2019

Document Id: 2704d4c4-3214-4a67-80b3-233ae6fabab2

34390-5

Set id: b73f9b1f-aa6f-468f-880e-a7fa4bcf930b

Version: 3

Effective Time: 20190910

 

Strategic Sourcing Services LLC