Label: FEXOFENADINE HYDROCHLORIDE- fexofenadine hydrochloride oral suspension
- NDC Code(s): 58602-426-20, 58602-426-24
- Packager: Aurohealth LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated June 6, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Purpose
- Uses
- Warnings
- Ask a doctor before use if you have
- When using this product
- Stop use and ask a doctor if
- PREGNANCY OR BREAST FEEDING
- Keep out of reach of children.
-
Directions
- 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?
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 8 fl. oz.(240 mL Bottle) Container Label
-
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 8 fl. oz. (240 mL Bottle) Carton Container Label
AUROHEALTH
NDC 58602-426-20
#Compare to the active Ingredient
in Children’s Allegra®AllergyAges 2 Years & Older
Children’s
Fexofenadine Hydrochloride
Oral Suspension
30 mg/5 mL
antihistamine 12 HR
NON-DROWSY
LiquidINDOOR / OUTDOOR ALLERGY RELIEF
√ Sneezing
√ Runny Nose
√ Itchy, Watery Eyes
√ Itchy Nose or Throat
Use Only With
Enclosed Dosing Cup
Wash and let air dry after each useBerry
FLAVOR
Alcohol & Dye FREE8 fl. oz. (240 mL)
-
INGREDIENTS AND APPEARANCE
FEXOFENADINE HYDROCHLORIDE
fexofenadine hydrochloride oral suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58602-426 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 STRAWBERRY (UNII: 4J2TY8Y81V) SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) EDETATE DISODIUM (UNII: 7FLD91C86K) ETHYLPARABEN (UNII: 14255EXE39) METHYLPARABEN (UNII: A2I8C7HI9T) MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T) SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN) POLOXAMER 407 (UNII: TUF2IVW3M2) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SUCROSE (UNII: C151H8M554) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) XANTHAN GUM (UNII: TTV12P4NEE) XYLITOL (UNII: VCQ006KQ1E) Product Characteristics Color WHITE Score Shape Size Flavor BERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58602-426-24 1 in 1 CARTON 05/23/2023 1 120 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package 2 NDC:58602-426-20 1 in 1 CARTON 05/23/2023 2 240 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA213466 05/23/2023 Labeler - Aurohealth LLC (078728447) Establishment Name Address ID/FEI Business Operations APL HEALTHCARE LIMITED 650918514 ANALYSIS(58602-426) , MANUFACTURE(58602-426)