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  5. Label Information: Maximum Strength Urinary Pain Relief

FDA Label for Maximum Strength Urinary Pain Relief

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. ACTIVE INGREDIENT (IN EACH TABLET)
    3. PURPOSE
    4. USE
    5. WARNINGS
    6. OTC - KEEP OUT OF REACH OF CHILDREN
    7. OTHER INFORMATION
    8. DIRECTIONS
    9. INACTIVE INGREDIENTS
    10. QUESTIONS?

Maximum Strength Urinary Pain Relief Product Label

The following document was submitted to the FDA by the labeler of this product Advanced Rx 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.

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 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.

• 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



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 items if handled after touching tablets.

• Store at room temperature between (59°F -86°F) 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


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