PHENAZOPYRIDINE HYDROCHLORIDE TABLETS
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each tablet)
Phenazopyridine Hydrochloride 95 mg
OTC - PURPOSE SECTION
Purpose
Urinary tract analgesic
INDICATIONS & USAGE SECTION
UseRelief from urinary pain, burning, urgency and frequency associated with urinary tract infections.
WARNINGS SECTION
Warnings
Ask a doctor before use if you have
- kidney disease
- allergies to foods, preservatives or dyes
- had a hypersensitive reaction to Phenazopyridine Hydrochloride
OTC - DO NOT USE SECTION
Do not useif you have Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency unless approved by your physician.
OTC - WHEN USING SECTION
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.
OTC - STOP USE SECTION
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.
OTC - PREGNANCY OR BREAST FEEDING SECTION
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.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.In case of an overdose, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
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 SECTION
Inactive ingredients carnauba wax, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized corn starch. May also contain corn starch.
Other Information
Tamper evident:Product is sealed within blisters. Do not use if any part of the blister is torn, open or damaged.
- 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.
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- 028-14
Phenazopyridine Hydrochloride Tablets, 95 mg
Urinary Tract Pain Relief
30 Tablets
Blister Label
- Relieves Pain, Burning and Urgency
- Targets the source of Pain