Dye Free Wal Fex Childrens Allergy: Package Insert and Label Information

DYE FREE WAL FEX CHILDRENS ALLERGY- fexofenadine hydrochloride suspension
Walgreens

Active ingredient (in each 5 mL)

Fexofenadine HCL, USP 30 mg

Purpose

Antihistamine

Uses

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

  • runny nose
  • sneezing
  • itchy, watery eyes
  • 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 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 (1-800-222-1222) right away.

Direction

  • shake well before using
  • use only with enclosed dosing cup
adults and children 12 years of age and over take 10 mL every 12 hours; do not take more than 20 mL in 24 hours
children 2 to under 12 years of age take 5 mL every 12 hours; do not take more than 10 mL in 24 hours
children under 2 years of age ask a doctor
adults 65 years of age and older ask a doctor
consumers with kidney disease ask a doctor

Note: mL = milliliters

Other information

  • each 5 mL contains: sodium 18 mg
  • store between 20º to 25ºC (68º and 77ºF)
  • before using any medication, read all label directions. Keep carton, it contains important information.

Inactive ingredients

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

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

*Compare to Children’s Allegra® Allergy active ingredient††

NON-DROWSY

2 YEARS & OLDER

Children’s Allergy

Dye-Free

Wal-Fex®

FEXOFENADINE HCL

ORAL SUSPENSION

30 mg PER 5 mL /

ANTIHISTAMINE

  • DYE FREE
  • NON-DROWSY
  • 12 — HOUR RELIEF
  • ALCOHOL FREE
  • Indoor/outdoor allergy relief of sneezing, runny nose itchy nose or throat & itchy, watery eyes

BERRY FLAVOR

FL OZ (mL)

Use only with enclosed dosing cup. Wash and let air dry after each use.

††This product is not manufactured or distributed by Chattem Inc., distributor of Children’s Allegra® Allergy.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

TAMPER EVIDENT: DO NOT USE IF CARTON, UNPRINTED FOIL INNER SEAL OR NECKBAND PRINTED WITH “SEAL FOR YOUR PROTECTION” IS OPENED, TORN OR MISSING

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

Product Label

Fexofenadine HCl, USP 30 mg
(click image for full-size original)

WALGREENS Children’s Allergy Dye-Free Wal-Fex

DYE FREE WAL FEX CHILDRENS ALLERGY
fexofenadine hcl suspension
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-9230
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) FEXOFENADINE HYDROCHLORIDE 30 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
BUTYLPARABEN
EDETATE DISODIUM
POLOXAMER 407
PROPYLENE GLYCOL
PROPYLPARABEN
WATER
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS
SUCROSE
TITANIUM DIOXIDE
XANTHAN GUM
XYLITOL
Product Characteristics
Color Score
Shape Size
Flavor BERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0363-9230-04 1 BOTTLE, PLASTIC in 1 BOX contains a BOTTLE, PLASTIC
1 118 mL in 1 BOTTLE, PLASTIC This package is contained within the BOX (0363-9230-04)
2 NDC:0363-9230-08 1 BOTTLE, PLASTIC in 1 BOX contains a BOTTLE, PLASTIC
2 237 mL in 1 BOTTLE, PLASTIC This package is contained within the BOX (0363-9230-08)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203330 06/01/2020
Labeler — Walgreens (008965063)

Revised: 08/2021 Walgreens

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