Label: CHILDRENS ALLERGY- fexofenadine hcl suspension
- NDC Code(s): 55319-923-04
- Packager: Family Dollar (FAMILY WELLNESS)
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated August 8, 2023
If you are a consumer or patient please visit this version.
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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?
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Principal Display Panel
COMPARE TO THE 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
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 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
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
DISTRIBUTED BY
MIDWOOD BRANDS, LLC
500 VOLVO PARKWAY,
CHESAPEAKE, VA 23320
- Product Label
-
INGREDIENTS AND APPEARANCE
CHILDRENS ALLERGY
fexofenadine hcl suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55319-923 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:55319-923-04 1 in 1 BOX 07/01/2023 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 07/01/2023 Labeler - Family Dollar (FAMILY WELLNESS) (024472631)