FEXOFENADINE HYDROCHLORIDE tablet

Fexofenadine Hydrochloride by

Drug Labeling and Warnings

Fexofenadine Hydrochloride by is a Otc medication manufactured, distributed, or labeled by Meijer Distribution, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient(s)

Fexofenadine HCl USP, 180 mg

Purpose

Antihistamine

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)

Stop use and ask doctor if

Allergy

an allergic reaction to this product occurs. Seek medical help right away.

Hives

• an allergic reaction to this product occurs. Seek medical help right away.

• symptoms do not improve after 3 days of treatment

• the hives have lasted more than 6 weeks

If pregnant or breast-feeding

ask a health professional before use.

Keep out of reach of children

In case of  overdose, get medical help or contact a Poison Control Center right away.

Directions

180 mg

• adults and children 12 years of age and over: take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours
• 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

safety sealed: do not use if carton is opened or if individual blister units are torn or opened.

Storage

store between 20° - 25°C (68° - 77°F)

protect from excessive moisture

this product meets the requirements of USP Dissolution Test 2.

Inactive ingredients

colloidal silicon dioxide, corn starch, croscarmellose sodium, magnesium stearate, mannitol, and powdered cellulose, opadry pink 03B54504 containing FD&C Red no. 40, hypromellose, iron oxide black, polyethylene glycol and titanium dioxide.

Questions or comments?

call toll-free 1-888-375-3784

Manufactured by:

Dr. Reddy’s Laboratories Limited

Bachupally - 500 090 INDIA

Principal Display Panel

Container Carton Label: 30 count

INGREDIENTS AND APPEARANCE

FEXOFENADINE HYDROCHLORIDE 
fexofenadine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41250-784(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: 41250-784-30	1 in 1 CARTON	12/29/2014
1		30 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 41250-784-90	1 in 1 CARTON	12/29/2014
2		90 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 41250-784-01	1 in 1 CARTON	12/29/2014
3		40 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	ANDA076502	12/29/2014

Labeler - Meijer Distribution, Inc (006959555)