Allergy Relief Tablet
FDA Label NDC 70677-1008

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Strategic Sourcing Services, Llc for the product Allergy Relief (NDC 70677-1008). 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 active ingredient(s), purpose, use(s), warnings, do not use, ask a doctor before use if you have, when using this product, stop use and ask doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient(S)

Fexofenadine HCl USP, 60 mg

Purpose

Antihistamine

Use(S)

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 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 over         take one 60 mg tablet with water once every 12 hours; do not take more than 2 tablets in 24 hours
children under 12 years of agedo not use
adults 65 years of age and olderask a doctor
consumers with kidney diseaseask a doctor

Other Information

  • safety sealed: do not use if carton is opened or if printed foil inner seal on bottle is torn or missing
  • store between 20° and 25°C (68° and 77°F)
  • protect from excessive moisture
  • this product meets the requirements of USP Dissolution Test 4

Inactive Ingredients

colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C Red no. 40, hypromellose, iron oxide black, magnesium stearate, mannitol, polyethylene glycol, powder cellulose and titanium dioxide

Questions?

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