FDA Label for Phenazopyridine Hydrochloride
View Indications, Usage & Precautions
Phenazopyridine Hydrochloride Product Label
The following document was submitted to the FDA by the labeler of this product Drug Ocean Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active ingredient (in each tablet)
Phenazopyridine Hydrochloride 99.5 mg
Otc - 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
Otc - Do Not Use
Do not useif you have Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency unless approved by your physician.
Otc - When Using
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
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
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
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
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
- Relieves Pain, Burning and Urgency
- Targets the source of Pain
12 Tablets
Blister Label
Drug Ocean NDC 70985- 029-13
Phenazopyridine Hydrochloride Tablets, 99.5 mg
Urinary Tract Pain Relief
24 Tablets
Blister Label
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