Label: FEXOFENADINE HYDROCHLORIDE tablet, film coated
-
Contains inactivated NDC Code(s)
NDC Code(s): 62756-545-15, 62756-545-17, 62756-545-18, 62756-545-19, view more62756-545-20, 62756-545-21, 62756-545-22, 62756-545-25, 62756-545-27, 62756-545-31, 62756-545-94 - Packager: Sun Pharmaceutical Industries, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated June 27, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Uses
-
Warnings
Severe Allergy Warning: Get emergency help immediately if 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
- drooling
- wheezing or problems breathing
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 prevent hives 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
- to prevent hives from any known cause such as:
- Ask a doctor before use if you have
- When using this product
- Stop use and ask doctor if
- If pregnant or breast-feeding
- Keep out of reach of children.
- Directions
- Other information
- Inactive ingredients
- Questions?
- Principal Display Panel
- Principal Display Panel
-
Principal Display Panel
For 180 mg : Blister Pack
NDC 62756-545-15
ORIGINAL PRESCRIPTION STRENGTH
NON-DROWSY
Fexofenadine Hydrochloride Tablets, USP
180 mg
HIVES
(24 Hour)
Reduces HIVES and Relieves ITCHING due to hives
Antihistamine
5 (1 x 5) Tablets
180 mg each
Actual Size
DO NOT USE IF INDIVIDUAL BLISTER UNIT IS OPEN OR TORN
- Principal Display Panel
-
INGREDIENTS AND APPEARANCE
FEXOFENADINE HYDROCHLORIDE
fexofenadine hydrochloride tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62756-545 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 MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) STARCH, CORN (UNII: O8232NY3SJ) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) MAGNESIUM STEARATE (UNII: 70097M6I30) HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) Product Characteristics Color PINK Score no score Shape CAPSULE Size 17mm Flavor Imprint Code 545 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62756-545-27 1 in 1 CARTON 06/30/2022 1 NDC:62756-545-31 5 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:62756-545-94 2 in 1 CARTON 06/30/2022 2 NDC:62756-545-31 5 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:62756-545-25 3 in 1 CARTON 06/30/2022 3 NDC:62756-545-31 5 in 1 BLISTER PACK; Type 0: Not a Combination Product 4 NDC:62756-545-15 30 in 1 BOTTLE; Type 0: Not a Combination Product 06/30/2022 5 NDC:62756-545-17 45 in 1 BOTTLE; Type 0: Not a Combination Product 06/30/2022 6 NDC:62756-545-18 70 in 1 BOTTLE; Type 0: Not a Combination Product 06/30/2022 7 NDC:62756-545-19 90 in 1 BOTTLE; Type 0: Not a Combination Product 06/30/2022 8 NDC:62756-545-20 150 in 1 BOTTLE; Type 0: Not a Combination Product 06/30/2022 9 NDC:62756-545-21 180 in 1 BOTTLE; Type 0: Not a Combination Product 06/30/2022 10 NDC:62756-545-22 300 in 1 BOTTLE; Type 0: Not a Combination Product 06/30/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091567 06/30/2022 Labeler - Sun Pharmaceutical Industries, Inc. (146974886) Establishment Name Address ID/FEI Business Operations Sun Pharmaceutical Industries Limited 650445203 ANALYSIS(62756-545) , MANUFACTURE(62756-545)