FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI tablet, extended release

Fexofenadine HCl and Pseudoephedrine HCI by

Drug Labeling and Warnings

Fexofenadine HCl and Pseudoephedrine HCI by is a Otc medication manufactured, distributed, or labeled by Dr.Reddy's Laboratories Limited, Dr.Reddy's Laboratories Limted (FTO III). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient(s)

Fexofenadine HCl USP, 180 mg

Pseudoephedrine HCl USP, 240 mg

Purpose

Antihistamine

Nasal decongestant

Use(s)

• temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
• runny nose
• sneezing
• itchy, watery eyes
• itching of the nose or throat
• temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
• reduces swelling of nasal passages
• temporarily relieves sinus congestion and pressure
• temporarily restores freer breathing through the nose

Warnings

Do not use

• if you have ever had an allergic reaction to this product or any of its ingredients
• if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
• if you have difficulty swallowing

Ask a doctor before use if you have

• heart disease
• thyroid disease
• glaucoma
• high blood pressure
• diabetes
• trouble urinating due to an enlarged prostate gland
• 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)
• the tablet coating may be seen in the stool (this is normal). Continue to take as directed (see Directions).

Stop use and ask doctor if

• an allergic reaction to this product occurs. Seek medical help right away.
• symptoms do not improve within 7 days or are accompanied by a fever
• you get nervous, dizzy, or sleepless

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

• do not divide, crush, chew or dissolve the tablet; swallow tablet whole

• adults and children 12 years of age and over: take 1 tablet with a glass of water every 24 hours on an empty stomach; 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
• store between 20° - 25°C (68° - 77°F)
• this product meets the requirements of USP Dissolution Test 4

Inactive ingredients

acetyltributyl citrate, colloidal silicon dioxide, copovidone, croscarmellose sodium, ethylcellulose, hydrogenated vegetable oil, hypromellose, microcrystalline cellulose, polyethylene glycol, sodium stearyl fumarate, talc and titanium dioxide.

Questions?

Call 1-888-375-3784

Manufactured by:

Dr. Reddy’s Laboratories Limited

Bachupally - 500 090 INDIA.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

Blister carton label : 10's

INGREDIENTS AND APPEARANCE

FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI 
fexofenadine hcl and pseudoephedrine hci tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55111-557
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
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	240 mg

Inactive Ingredients
Ingredient Name	Strength
ACETYLTRIBUTYL CITRATE (UNII: 0ZBX0N59RZ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)
COPOVIDONE (UNII: D9C330MD8B)
HYPROMELLOSES (UNII: 3NXW29V3WO)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
Polyethylene Glycol, Unspecified (UNII: 3WJQ0SDW1A)
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
HYDROGENATED COTTONSEED OIL (UNII: Z82Y2C65EA)

Product Characteristics
Color	WHITE	Score	no score
Shape	CAPSULE	Size	21mm
Flavor		Imprint Code	RDY;572
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55111-557-07	1 in 1 CARTON	08/24/2011
1		5 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 55111-557-35	2 in 1 CARTON	08/24/2011
2		5 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 55111-557-29	3 in 1 CARTON	08/24/2011
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	ANDA079043	08/24/2011

Labeler - Dr.Reddy's Laboratories Limited (650562841)

Establishment
Name	Address	ID/FEI	Business Operations
Dr.Reddy's Laboratories Limted (FTO III)		918608162	analysis(55111-557) , manufacture(55111-557)