Valumeds 24-hour Allergy Relief Tablet
FDA Label NDC 82725-1002

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cabinet Health P.b.c. for the product Valumeds 24-hour Allergy Relief (NDC 82725-1002). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, active ingredient (in each tablet), purpose, uses, warnings, do not use, ask a doctor before use if you have, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Drug Facts

Active Ingredient (In Each Tablet)

Fexofenadine HCl USP, 180 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • runny nose  
  • itchy, watery eyes 
  • sneezing  
  • itching of the nose or throat 

Warnings

Do Not Use

if you have ever had an allergic reaction to this product or any of its ingredients 

Ask A Doctor Before Use If You Have

kidney disease. Your doctor should determine if you need a different dose.

When Using This Product

  • do not take more than directed 
  • do not take at the same time as aluminum or magnesium antacids 
  • do not take with fruit juices (see Directions)

Stop Use And Ask A Doctor If

an allergic reaction to this product occurs. Seek medical help right away.

If Pregnant Or Breast-Feeding:

ask a health professional before use

Keep Out Of Reach Of Children.

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

Directions

 adults and children 12 years of age and overtake one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours
children under 6 years
of age
do not use
adults 65 years of age
and older
ask a doctor 
 consumers with kidney diseaseask a doctor 

Other Information

  • safety sealed: do not use if imprinted foil under bottle cap is opened or torn
  • store between 20° and 25°C (68° and 77°F)
  • protect from excessive moisture

Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, macrogol, magnesium stearate, microcrystalline cellulose, pregelatinized starch, titanium dioxide

Questions?

call 1-908-242-6108Mon-Fri 8:00 AM to 5:00 PM EST

Package Labelling:

Label (Label)

Label (Label)

* Please review the disclaimer below.