CVS Maximum Strength Urinary Pain Relief: Package Insert and Label Information

CVS MAXIMUM STRENGTH URINARY PAIN RELIEF- phenazopyridine hydrochloride tablet

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Active ingredient (in each tablet)

Phenazopyridine Hydrochloride 99.5 mg .


Urinary Analgesic


Do not exceed recommended dosage

Ask doctor before use if you have

■ kidney disease
■ allergies to food, preservatives or dyes
■ had a hypersensitive reaction to phenazopyridine

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 breast feeding,

Ask a health professional before use.

Keep out of reach of children

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


Fast relief from urinary pain, burning, urgency and frequency associated with urinary tract

Inactive ingredients

Lactose, magnesium silicate, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, and sodium starch glycolate.


■ adults and children 12 years and over:
take 2 tablets 3 times daily with a full glass of water, with or after meals as needed

■ children under 12 years: consult a doctor

■ Do not use for more than 2 days (12 tablets) without consulting a doctor

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CVS MAXIMUM STRENGTH URINARY PAIN RELIEF phenazopyridine hydrochloride tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-713
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Inactive Ingredients
Ingredient Name Strength
Product Characteristics
Color brown Score no score
Shape OVAL Size 9mm
Flavor Imprint Code p99
# Item Code Package Description Multilevel Packaging
1 NDC:69842-713-24 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 24 TABLET in 1 BLISTER PACK This package is contained within the CARTON (69842-713-24)
2 NDC:69842-713-12 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 12 TABLET in 1 BLISTER PACK This package is contained within the CARTON (69842-713-12)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 09/18/2019
Labeler — CVS PHARMACY INC (062312574)
Registrant — Reese Pharmaceutical Co (004172052)
Name Address ID/FEI Operations
Reese Pharmaceutical Co 004172052 relabel (69842-713), repack (69842-713)

Revised: 09/2021 CVS PHARMACY INC provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

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