SKOPKO URINARY PAIN RELIEF- phenazopyridine hydrochloride tablet

Skopko Urinary Pain Relief by

Drug Labeling and Warnings

Skopko Urinary Pain Relief by is a Otc medication manufactured, distributed, or labeled by Skopko, Reese Pharmaceutical Co. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

magnesium stearate,microcrystalline cellulose.May also contain carnauba wax,

croscarmellose sodium,hypromellose,lactose,magnesium silicate,maize starch,pharmaceutical

glaze,polyethylene glycol,povidone,pregelatinized starch,sodium starch glycolate.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SKOPKO URINARY PAIN RELIEF  
phenazopyridine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37012-098
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
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE (UNII: J2B2A4N98G)
MAGNESIUM SILICATE (UNII: 9B9691B2N9)

Product Characteristics
Color	red	Score	no score
Shape	ROUND	Size	7mm
Flavor		Imprint Code	CPC64
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37012-098-01	1 in 1 CARTON	07/01/2013
1	NDC: 37012-098-50	32 in 1 CELLO PACK; Type 0: Not a Combination Product
2	NDC: 37012-098-30	30 in 1 CELLO PACK; Type 0: Not a Combination Product	07/01/2013

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

Labeler - Skopko (023252638)

Registrant - Reese Pharmaceutical Co (004172052)

Establishment
Name	Address	ID/FEI	Business Operations
Reese Pharmaceutical Co		004172052	relabel(37012-098) , repack(37012-098)