Label: ALLERGY RELIEF- fexofenadine hydrochloride tablet
- NDC Code(s): 49035-784-29, 49035-784-30, 49035-784-43
- Packager: Wal-Mart Stores, Inc.
- This is a repackaged label.
- Source NDC Code(s): 55111-784
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated December 10, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient(s)
- Purpose
-
Use(s)
Allergy
temporarily relieves these symptoms due to hay fever or otherupper respiratory allergies:
- runny nose
- itchy, watery eyes
- sneezing
- itching of the nose or throat
Hives
reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occuring.
-
Warnings
Hives
Severe Allergic Warning: Get emergency help immediately if you have hives along with any of the following symptom:
- 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 canbe life threatening if not treated by a health professional immediately.Symptoms of anaphylactic shock may occur when hives first appear or upto a few hours later.
Not a Substitute for Epinephrine. If your doctor has prescribed an epinephrineinjector for “anaphylaxis” or severe allergy symptoms that could occur withyour hives, never use this product as a substitute for the epinephrine injector.If you have been prescribed an epinephrine injector, you should carry it withyou at all times.
Do not use
Allergy
if you have ever had an allergic reaction to this product or any of its ingredients.
Hives
- 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
Ask a doctor before use if you have
Allergy
- kidney disease. Your doctorshould determine if you need a different dose.
Hives
- 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)
- Directions
- Other information
- Storage
- Inactive ingredients
- Questions or comments?
- Container Label: 30 count
- Container Carton Label: 30 count
- Blister Carton Label: 15 count
-
INGREDIENTS AND APPEARANCE
ALLERGY RELIEF
fexofenadine hydrochloride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-784(NDC:55111-784) 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 SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) magnesium stearate (UNII: 70097M6I30) mannitol (UNII: 3OWL53L36A) POWDERED CELLULOSE (UNII: SMD1X3XO9M) FD&C RED NO. 40 (UNII: WZB9127XOA) HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6) FERROSOFERRIC OXIDE (UNII: XM0M87F357) polyethylene glycol 400 (UNII: B697894SGQ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color PINK Score no score Shape OVAL Size 7mm Flavor Imprint Code 194;R Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49035-784-30 1 in 1 CARTON 04/13/2011 1 30 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:49035-784-43 2 in 1 CARTON 04/13/2011 2 30 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:49035-784-29 3 in 1 CARTON 04/13/2011 3 5 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 ANDA076502 04/13/2011 Labeler - Wal-Mart Stores, Inc. (051957769)
