Childrens Fexofenadine Hydrochloride Suspension
FDA Label NDC 51672-2141

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sun Pharmaceutical Industries, Inc. for the product Childrens Fexofenadine Hydrochloride (NDC 51672-2141). 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 5 ml), 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:
Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532

Active Ingredient (In Each 5 Ml)

Fexofenadine HCl 30 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.

Directions

  • shake well before using
  • use only with enclosed dosing cup
    • Note: mL = milliliters
    adults and children 12 years of age and overtake 10 mL every 12 hours; do not take more than 20 mL in 24 hours
    children 2 to under 12 years of agetake 5 mL every 12 hours; do not take more than 10 mL in 24 hours
    children under 2 years of ageask a doctor
    adults 65 years of age and olderask a doctor
    consumers with kidney diseaseask a doctor

Other Information

  • each 5 mL contains: sodium 14 mg
  • safety sealed: do not use if carton is opened, or if imprinted safety seal is broken or missing.
  • store between 20° and 25°C (68° and 77°F)

Inactive Ingredients

artificial raspberry flavor, edetate disodium, maltitol solution, poloxamer 407, potassium sorbate, propylene glycol, purified water, sodium benzoate, sodium phosphate dibasic heptahydrate, sodium phosphate monobasic monohydrate, sucralose powder, titanium dioxide and xanthan gum

Questions?

Call 1-866-923-4914

Principal Display Panel - 120 Ml Bottle Carton

NDC 51672-2141-8

Compare to the active
ingredient in Children's
Allegra® Allergy*

Children's
Allergy
Fexofenadine HCl
Oral Suspension,
30 mg/ 5 mL
Antihistamine

NON-DROWSY

12
Hour

Berry Flavor

2
Years
& Older

INDOOR/OUTDOOR
ALLERGY RELIEF

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

    • Dye free / Alcohol free / Sugar free

    LIQUID
    Oral Suspension

    4 fl. oz.
    (120 mL)

    Principal Display Panel (120 mL Bottle Carton)

    Principal Display Panel (120 mL Bottle Carton)

* Please review the disclaimer below.