Label: CHILDRENS FEXOFENADINE HYDROCHLORIDE ALLERGY- fexofenadine hydrochloride suspension
- NDC Code(s): 51672-2141-1, 51672-2141-8
- Packager: Taro Pharmaceuticals U.S.A., Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated January 25, 2024
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- 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)
-
Directions
- shake well before using
- use only with enclosed dosing cup
Note: mL = milliliters 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 - Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
-
PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton
NDC 51672-2141-8
Compare to the active
ingredient in Children's
Allegra® Allergy*Children's
Allergy
Fexofenadine HCl
Oral Suspension,
30 mg/ 5 mL
AntihistamineNON-DROWSY
12
HourBerry Flavor
2
Years
& OlderINDOOR/OUTDOOR
ALLERGY RELIEF- ✓
- Sneezing
- ✓
- Runny Nose
- ✓
- Itchy, Watery Eyes
- ✓
- Itchy Nose or Throat
Dye free / Alcohol free / Sugar free
LIQUID
Oral Suspension4 fl. oz.
(120 mL) -
INGREDIENTS AND APPEARANCE
CHILDRENS FEXOFENADINE HYDROCHLORIDE ALLERGY
fexofenadine hydrochloride suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51672-2141 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 edetate disodium (UNII: 7FLD91C86K) maltitol (UNII: D65DG142WK) poloxamer 407 (UNII: TUF2IVW3M2) propylene glycol (UNII: 6DC9Q167V3) water (UNII: 059QF0KO0R) SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (UNII: 70WT22SF4B) SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN) sucralose (UNII: 96K6UQ3ZD4) potassium sorbate (UNII: 1VPU26JZZ4) titanium dioxide (UNII: 15FIX9V2JP) xanthan gum (UNII: TTV12P4NEE) sodium benzoate (UNII: OJ245FE5EU) Product Characteristics Color WHITE (white to off-white) Score Shape Size Flavor RASPBERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51672-2141-8 1 in 1 CARTON 01/24/2024 1 120 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:51672-2141-1 1 in 1 CARTON 01/24/2024 2 240 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA208123 01/24/2024 Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370)