FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCL tablet, extended release

Fexofenadine HCl and Pseudoephedrine HCl by

Drug Labeling and Warnings

Fexofenadine HCl and Pseudoephedrine HCl by is a Otc medication manufactured, distributed, or labeled by Dr.Reddy's Laboratories Inc, Dr.Reddy's Laboratories Limited (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

• each tablet contains: 28 mg sodium
• 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)
• FDA approved dissolution test specifications differ from USP

Inactive ingredients

acetone, black iron oxide, cellulose acetate, colloidal silicon dioxide, copovidone, croscarmellose sodium, FD&C blue #1 aluminum lake, hypromellose, isopropyl alcohol, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, propylene glycol, red iron oxide, sodium chloride, talc, titanium dioxide, water

Questions?

Questions?Call 1-888-375-3784 Weekdays (9am - 8pm EST)

Distributed by:

Dr. Reddy’s Laboratories, Inc.

Princeton, NJ 08540

Carton Label

Blister carton label : 5's

NDC- 43598-892-07

Distributed by:

Dr. Reddy's Laboratories Inc,

Princeton, NJ- 08540

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43598-892
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
ACETONE (UNII: 1364PS73AF)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CELLULOSE ACETATE (UNII: 3J2P07GVB6)
COPOVIDONE (UNII: D9C330MD8B)
HYPROMELLOSES (UNII: 3NXW29V3WO)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
Polyethylene Glycol, Unspecified (UNII: 3WJQ0SDW1A)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)
MAGNESIUM STEARATE (UNII: 70097M6I30)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
FERRIC OXIDE RED (UNII: 1K09F3G675)
POVIDONE K30 (UNII: U725QWY32X)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	12mm
Flavor		Imprint Code	892
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43598-892-07	1 in 1 CARTON	05/17/2022	10/31/2024
1		5 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 43598-892-35	2 in 1 CARTON	05/17/2022	08/31/2026
2		5 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 43598-892-29	3 in 1 CARTON	05/17/2022	07/30/2026
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	05/17/2022	08/31/2026

Labeler - Dr.Reddy's Laboratories Inc (802315887)

Establishment
Name	Address	ID/FEI	Business Operations
Dr.Reddy's Laboratories Limited (FTO III)		918608162	analysis(43598-892) , manufacture(43598-892)