PHENAZOPYRIDINE HYDROCHLORIDE tablet

PHENAZOPYRIDINE HYDROCHLORIDE by

Drug Labeling and Warnings

PHENAZOPYRIDINE HYDROCHLORIDE by is a Otc medication manufactured, distributed, or labeled by Drug Ocean LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient (in each tablet)

Phenazopyridine Hydrochloride 99.5 mg

PURPOSE

Purpose

Urinary tract analgesic

INDICATIONS & USAGE

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

WARNINGS

Warnings

Ask a doctor before use if you have

• kidney disease
• allergies to foods, preservatives or dyes
• had a hypersensitive reaction to Phenazopyridine Hydrochloride

Do not useif you have Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency unless approved by your physician.

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 breastfeeding,ask a healthcare professional before use. A pregnancy test and consultation with a healthcare professional if pregnancy is confirmed is recommended prior to use. 

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

DOSAGE & ADMINISTRATION

Directions

• Adults and children 12 years and older: Take 2 tablets 3 times daily with or after meals as needed for up to two days. Take with a full glass of water. Do not use for more than 2 days (12 tablets) without consulting a doctor. 
• Children under 12: Do not use without consulting a doctor.

INACTIVE INGREDIENT

Inactive ingredients  carnauba wax, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized corn starch. May also contain corn starch.

OTHER SAFETY INFORMATION

Other Information

• This product contains Phenazopyridine Hydrochloride, known to the State of California to cause cancer
• This product can interfere with laboratory tests including urine, glucose (sugar), and ketones tests
• This product may stain soft contact lenses and other items if handled after touching tablets
• Store at room temperature (59 o-86 oF) in a dry place and protect from light.

Tamper evident:Product is sealed within blisters. Do not use if any part of the blister is torn, open or damaged.

SPL UNCLASSIFIED SECTION

Questions or comments? Call 1-844-200-6566

Distributed by:
Drug Ocean LLC
1 Bridge Plaza, North Central Road,
6th Floor, Suite 675,
Fort Lee, NJ 07024

Made in India

Mfg License Code:
RA/Drug/RAJ.-1750

ORG 03/2024

Packaging

Drug Ocean NDC 70985- 029-09

Phenazopyridine Hydrochloride Tablets, 99.5 mg

Urinary Tract Pain Relief

• Relieves Pain, Burning and Urgency
• Targets the source of Pain

12 Tablets

Blister Label

Packaging

Drug Ocean NDC 70985- 029-13

Phenazopyridine Hydrochloride Tablets, 99.5 mg

Urinary Tract Pain Relief

• Relieves Pain, Burning and Urgency
• Targets the source of Pain

24 Tablets

Blister Label

INGREDIENTS AND APPEARANCE

PHENAZOPYRIDINE HYDROCHLORIDE 
phenazopyridine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70985-029
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENAZOPYRIDINE HYDROCHLORIDE (UNII: 0EWG668W17) (PHENAZOPYRIDINE - UNII:K2J09EMJ52)	PHENAZOPYRIDINE HYDROCHLORIDE	99.5 mg

Inactive Ingredients
Ingredient Name	Strength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	red (Maroon)	Score	no score
Shape	CAPSULE	Size	9mm
Flavor		Imprint Code	p99
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70985-029-09	1 in 1 CARTON	03/12/2024
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 70985-029-13	1 in 1 CARTON	03/12/2024
2		24 in 1 BLISTER 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		03/12/2024

Labeler - Drug Ocean LLC (080381835)