Label: CHILDRENS ALLERGY- fexofenadine hcl suspension
- NDC Code(s): 55319-957-04
- Packager: Family Dollar (FAMILY WELLNESS)
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated June 4, 2024
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- Official Label (Printer Friendly)
- Active ingredient (in each 5 mL)
- Purpose
- Uses
-
Warnings
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)
-
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
- Inactive ingredients
- Questions or comments?
-
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
-
INGREDIENTS AND APPEARANCE
CHILDRENS ALLERGY
fexofenadine hcl suspensionProduct 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)