CHILDRENS ALLERGY- fexofenadine hcl suspension

Childrens Allergy by

Drug Labeling and Warnings

Childrens Allergy by is a Otc medication manufactured, distributed, or labeled by Family Dollar (FAMILY WELLNESS). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 17 mg
• store between 20º to 25ºC (68º and 77ºF)

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 ACTIVE INGREDIENT IN CHILDREN'S ALLEGRA® ALLERGY*

Children's

ALLERGY

AGES 2 YEARS & UP

FEXOFENADINE HCl

ORAL SUSPENSION

30 mg/5mL

Antihistamine

Indoor/Outdoor allergy relief

• Sneezing
• Runny Nose
• Itchy, watery eyes
• Itchy nose or throat

12 Hour Relief

Non-drowsy

Alcohol-free

DYE-FREE

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 Sanofi Consumer Healthcare NA, distributor of Children's Allegra® Allergy.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF SEAL ON BOTTLE  PRINTED WITH "SEALED FOR SAFETY" IS TORN OR MISSING.

DISTRIBUTED BY:

MIDWOOD BRANDS, LLC,

500 VOLVO PKWY,

CHESAPEAKE, VA 23320

Product Label

FAMILY WELLNESS Children's Allergy Dye-Free Berry Flavor

INGREDIENTS AND APPEARANCE

CHILDRENS ALLERGY 
fexofenadine hcl suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55319-957
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V)	FEXOFENADINE HYDROCHLORIDE	30 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYLPARABEN (UNII: 3QPI1U3FV8)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POLOXAMER 407 (UNII: TUF2IVW3M2)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)
SUCROSE (UNII: C151H8M554)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
XANTHAN GUM (UNII: TTV12P4NEE)
XYLITOL (UNII: VCQ006KQ1E)

Product Characteristics
Color		Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55319-957-04	1 in 1 BOX	10/31/2023
1		118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA203330	10/31/2023

Labeler - Family Dollar (FAMILY WELLNESS) (024472631)