Label: FEXOFENADINE HYDROCHLORIDE- fexofenadine hydrochloride tablet, film coated
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NDC Code(s):
62207-889-49,
62207-889-51,
62207-889-60,
62207-891-49, view more62207-891-51, 62207-891-58
- Packager: Granules India Limited
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated November 13, 2023
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Uses
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Warnings
Severe Allergy Warning:Get emergency help immediatelyif you have hives along with any of the following symptoms:
- trouble swallowing
- dizziness or loss of consciousness
- swelling of tongue
- swelling in or around mouth
- trouble speaking
- wheezing or problems breathing
- drooling
These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a health professional immediately. Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later.
Not a Substitute for Epinephrine.If your doctor has prescribed an epinephrine injector for “anaphylaxis” or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times.Do not use
- to preventhives from any known cause such as:
- foods
- insect stings
- medicines
- latex or rubber gloves
because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause.
- 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.
- hives that are an unusual color, look bruised or blistered
- hives that do not itch
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)
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Directions
adults and children 12 years of age and over take one 60 mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hours (for 60 mg)
take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours (for 180 mg)children under 12 years of age do not use adults 65 years of age and older ask a doctor consumers with kidney disease ask a doctor - Other information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL 60 mg - 10s Container Label
- PRINCIPAL DISPLAY PANEL 60 mg - 10s Container Carton
- PRINCIPAL DISPLAY PANEL 60 mg - Blister Carton
- PRINCIPAL DISPLAY PANEL 180 mg - 10s Container Label
- PRINCIPAL DISPLAY PANEL 180 mg - 10s Container Carton
- PRINCIPAL DISPLAY PANEL 180 mg - Blister Carton
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INGREDIENTS AND APPEARANCE
FEXOFENADINE HYDROCHLORIDE
fexofenadine hydrochloride tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62207-889 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) FEXOFENADINE HYDROCHLORIDE 60 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color orange (PEACH) Score no score Shape OVAL Size 12mm Flavor Imprint Code G5 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62207-889-51 1 in 1 CARTON 11/07/2023 1 10 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:62207-889-49 1000 in 1 BOTTLE; Type 0: Not a Combination Product 11/07/2023 3 NDC:62207-889-60 8 in 1 CARTON 11/07/2023 3 9 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA211075 11/07/2023 FEXOFENADINE HYDROCHLORIDE
fexofenadine hydrochloride tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62207-891 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) FEXOFENADINE HYDROCHLORIDE 180 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color orange (PEACH) Score no score Shape CAPSULE (CAPSULE) Size 17mm Flavor Imprint Code G6 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62207-891-51 1 in 1 CARTON 11/07/2023 1 10 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:62207-891-49 1000 in 1 BOTTLE; Type 0: Not a Combination Product 11/07/2023 3 NDC:62207-891-58 7 in 1 CARTON 11/07/2023 3 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA211075 11/07/2023 Labeler - Granules India Limited (915000087)