Allergy Relief Tablet
FDA Label NDC 21130-784

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Safeway Inc for the product Allergy Relief (NDC 21130-784). 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, 180 mg

Purpose

Antihistamine

Use(S)

Allergy

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

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

    • Hives

    reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction  from occuring.



Warnings

Hives

Severe Allergic Warning: Get emergency help immediately if you have hives along with any of the following symptom:

  • trouble swallowing  
  • dizziness or loss of consciousness 
  • swelling of tongue  
  • swelling in or around mouth 
  • trouble speaking 
  • drooling 
  • wheezing or problems breathing  

    • These symptoms may be signs of anaphylactic shock. This condition canbe life threatening if not treated by a health professional immediately.Symptoms of anaphylactic shock may occur when hives first appear or upto a few hours later.

    Not a Substitute for Epinephrine. If your doctor has prescribed an epinephrineinjector for “anaphylaxis” or severe allergy symptoms that could occur withyour hives, never use this product as a substitute for the epinephrine injector.If you have been prescribed an epinephrine injector, you should carry it withyou at all times.

Do Not Use

Allergy

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

Hives

  • to prevent hives from any known cause such as: 
    • foods
    • insect stings
    • medicines
    • latex or rubber gloves

      • because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause.

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

Ask A Doctor Before Use If You Have

Allergy

  • kidney disease. Your doctorshould determine if you need a different dose.

    • Hives

    • kidney disease. Your doctor should determine if you need a different dose.
    • hives that are an unusual color, look bruised or blistered
    • hives that do not itch

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

Allergy

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

Hives

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

  • symptoms do not improve after 3 days of treatment

  • the hives have lasted more than 6 weeks

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

180 mg

adults and children 12 years of age and over         take one 180 mg tablet with water once a day; do not take more than 1 tablet 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 individual blister units are torn or opened.

Storage

store between 20° - 25°C (68° - 77°F)

protect from excessive moisture

this product meets the requirements of USP Dissolution Test 2.

Inactive Ingredients

colloidal silicon dioxide, corn starch, croscarmellose sodium, magnesium stearate, mannitol, and powdered cellulose, opadry pink 03B54504 containing FD&C Red no. 40, hypromellose, iron oxide black, polyethylene glycol and titanium dioxide.

Questions Or Comments?

call toll-free 1-888-375-3784

Manufactured by:

Dr. Reddy’s Laboratories Limited

Bachupally - 500 090 INDIA

Containercarton

Container Carton Label: 30 count

Containercarton (Containercarton)

Containercarton (Containercarton)

Blister Carton Label: 15 Count

Blister Carton Label: 15 count

Blistercarton (Blistercarton)

Blistercarton (Blistercarton)

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