Childrens Allegra Allergy Suspension
FDA Label NDC 41167-4244

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Chattem, Inc. for the product Childrens Allegra Allergy (NDC 41167-4244). 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, purpose, uses, do not use, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

(in each 5 mL teaspoonful)

Fexofenadine HCI 30 mg

Purpose

Antihistamine

Uses

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

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

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

  • shake well before using
  • use only with enclosed dosing cup
    • adults and children 12 years of age and overtake 2 teaspoonfuls (10 mL) every 12 hours; do not take more than 4 teaspoonfuls (20 mL) in 24 hours
    children 2 to under 12 years of agetake 1 teaspoonful (5 mL) every 12 hours; do not take more than 2 teaspoonfuls (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

    Note: teaspoonful = tsp

Other Information

  • each 5 mL teaspoon contains: sodium 18 mg
  • 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)

Inactive Ingredients

butylparaben, edetate disodium, flavor, poloxamer 407, propylene glycol, propylparaben, purified water, sodium phosphate dibasic heptahydrate, sodium phosphate monobasic monohydrate, sucrose, titanium dioxide, xanthan gum, xylitol

Questions Or Comments?

call toll-free 1-800-633-1610 or www.allegra.com

Principal Display Panel

NDC 41167-4244-4
Children’s
Allegra® 
Allergy
fexofenadine HCL oral suspension
30 mg/5 ml antihistamine

Ndc 41167-4244-4children’s Allegra® Allergyfexofenadine HCl Oral Suspension 30 mg/5 mL Antihistamine (Childrens Allegra Allergy Oral Suspension 01)

Ndc 41167-4244-4children’s Allegra® Allergyfexofenadine HCl Oral Suspension 30 mg/5 mL Antihistamine (Childrens Allegra Allergy Oral Suspension 01)

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