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Maximum Strength Urinary Pain Relief Dailymed


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Drug Facts


Active Ingredient (in Each Tablet)


Phenazopyridine Hydrochloride 99.5 mg 

Purpose


Urinary tract analgesic

Use


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

Warnings


Do not exceed recommended dosage.

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 lis.

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.

• Long-term administration of phenazopyridine hydrochloride has induced neoplasia in rats (large intestine) and mice (liver). Although no association between phenazopyridine hydrochloride and human neoplasia has been reported, adequate epidemiological studies along these lines have not been conducted.

If pregnant or breastfeeding, ask a health professional before use.  A pregnancy test and consultation with a health 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.

Other Information


• This product can interfere with laboratory tests including urine, glucose (sugar), and ketones tests

• This product may stain contact lenses and other lis if handled after touching tablets.

• Store at room temperature between (59ºF -86ºF) in a dry place and protect from light.

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 years:Do not use without consulting a doctor

Inactive Ingredients


pregelatinized starch, microcrystalline cellulose, maize (corn) strach, povidone, croscarmellose sodium, magnesium stearate, colloidal silicone dioxide, hydroxypropyl methylcellulose, polyethylene glycol.

Questions?


call toll-free 1-800-630-8895

Package Label.principal Display Panel


Compare to the active ingredient in  AZO Urinary Pain Relief ®Maximum Strength*  

NDC 80513-517-72

Maximum Strength Urinary Pain Relief

99.5 mg Phenazopyridine Hydrochloride

#1 DOCTOR RECOMMENDED OTC INGREDIENT FOR UTI PAIN

TEMPORARY RELIEF OF URINARY PAIN, BURNING & URGENCY

Urinary Analgesic

72 Tablets

DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED

Size and color of tablet may very.

WARNING: This product can expose you to chemicals including phenazopyridine hydrochloride, which is known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov.

*This product is not manufactured or distributed by I-Health, Inc., owner of the registered trademark of AZO Urinary Pain Relief ®Maximum Strength

Distributed by:

ADVANCED RX LLC,

1942 NE 163rd St North Miami Beach,

FL 33162 U.S.A.

MADE IN USA



DISCLAIMER:

"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."

"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."

"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

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