Fexofenadine Hydrochloride Tablet, Film Coated
FDA Label NDC 51660-998

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Ohm Laboratories Inc. for the product Fexofenadine Hydrochloride (NDC 51660-998). 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 other, active ingredient (in each tablet), purpose, uses, otc - do not use, otc - ask doctor, when using this product, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Distributed by:
Ohm Laboratories Inc.
New Brunswick, NJ 08901
MADE IN INDIA

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

Otc - Do Not Use

Do not use if you have ever had an allergic reaction to this product or any of its ingredients

Otc - Ask Doctor

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)

Otc - Stop Use

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

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 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 inner safety seal is torn or missing
  • store between 20° to 25°C (68° to 77°F)
  • protect from excessive moisture

Inactive Ingredients

croscarmellose sodium, hypromellose, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized maize starch, titanium dioxide

Questions Or Comments?

Call toll-free weekdays 8:30 AM to 5 PM EST at 1-800-818-4555.

Principal Display Panel - 180 Mg Tablet Bottle Carton

†Compare To
the active ingredient of
Allegra® Allergy

NDC 51660-998-30

NDC 51660-998-55

NON-DROWSY

Fexofenadine Hydrochloride
Tablets, USP 180 mg

Antihistamine

Indoor and Outdoor Allergies

ALLERGY

24 Hour
Relief of:

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Nose or Throat

    • ohm®

    30 Tablets

    DO NOT USE IF INNER SAFETY SEAL IMPRINTED WITH
    "SEALED for YOUR PROTECTION" IS TORN OR MISSING

    Principal Display Panel (180 mg Tablet Bottle Carton)

    Principal Display Panel (180 mg Tablet Bottle Carton)

* Please review the disclaimer below.