24 HR Fexofenadine hydrochloride 180 MG / Pseudoephedrine Hydrochloride 240 MG Extended Release Tablet

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Pill Identifier Information of 24 HR Fexofenadine hydrochloride 180 MG / Pseudoephedrine Hydrochloride 240 MG Extended Release Tablet

Drug Information

Imprint:	RDY;572
Shape:	C48336
Color:	C48325
Ingredients:	fexofenadine; Pseudoephedrine
Size:	21.00
Score:	1
Rxtty:	SCD
Author:	Dr.Reddy's Laboratories Limited
Inactive Ingredients:	ACETYLTRIBUTYL CITRATE / CROSCARMELLOSE SODIUM / ETHYLCELLULOSES / COPOVIDONE / HYPROMELLOSES / CELLULOSE, MICROCRYSTALLINE / POLYETHYLENE GLYCOL / SODIUM STEARYL FUMARATE / TALC / TITANIUM DIOXIDE / COLLOIDAL SILICON DIOXIDE / HYDROGENATED COTTONSEED OIL>

Complete Information

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 Parkinsonâ€™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 overÂ Â	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 ageÂ 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 20Â° - 25Â°C (68Â° - 77Â°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. Reddyâ€™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 HCIÂ
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V)	FEXOFENADINE HYDROCHLORIDE	180Â mg
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	240Â mg

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

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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA079043	08/24/2011

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

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