Childrens Fexofenadine Hydrochloride

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Fexofenadine HCl 30 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a different dose.

OTC - WHEN USING SECTION

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 SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• shake well before using
• use only with enclosed dosing cup

Note: mL = milliliters
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

Other information

STORAGE AND HANDLING SECTION

• each 5 mL contains: sodium 9 mg
• safety sealed: do not use if carton is opened or if foil inner seal on bottle is torn or missing
• store between 20° and 25°C (68° and 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

Call 1-866-923-4914

SPL UNCLASSIFIED SECTION

Distributed by:
Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

NDC 51672-2119-8

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)

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

• Childrens Fexofenadine Hydrochloride Allergy
• Fexofenadine Hydrochloride
• Fexofenadine
• butylparaben
• edetate disodium
• maltitol
• poloxamer 407
• propylene glycol
• propylparaben
• water
• sodium phosphate, dibasic, heptahydrate
• sodium phosphate, monobasic, monohydrate
• sucralose
• titanium dioxide
• xanthan gum

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Source Document#

Source XML

Orange Book application contexts#

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Orange Book application contexts page 1 of 1 · 1 matching rows.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 86 observed states.

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Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.