CHILDRENS ALLERGY- fexofenadine hydrochloride suspension 
H2-Pharma, LLC

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Children's Allergy

Drug Facts

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:

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.

Directions

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

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

Distributed by: H2-Pharma, LLC
Montgomery, AL 36117

PRINCIPAL DISPLAY PANEL - 237 mL Bottle Carton

NDC 61269-527-98

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

Children's
Allergy

Fexofenadine HCl
Oral Suspension 30 mg/5 mL

Antihistamine

Indoor/Outdoor allergy relief
Sneezing
Runny nose
Itchy, watery eyes
Itchy nose or throat

12 Hour Relief
Ages 2 years and older
Non-drowsy
Dye-free
Alcohol-free

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

BERRY FLAVOR

8 fl oz (237 mL)

H2 pharma

PRINCIPAL DISPLAY PANEL - 237 mL Bottle Carton
CHILDRENS ALLERGY 
fexofenadine hydrochloride suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61269-527
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) FEXOFENADINE HYDROCHLORIDE30 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61269-527-941 in 1 CARTON07/18/2022
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:61269-527-981 in 1 CARTON07/18/2022
2237 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20333007/18/2022
Labeler - H2-Pharma, LLC (028473634)

Revised: 7/2022
Document Id: 53bebdb2-1a62-40b9-8cd3-407cc2a70037
Set id: 84988f6d-85b1-45dd-89be-0333acc6b180
Version: 1
Effective Time: 20220720
 
H2-Pharma, LLC