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 RUGBY LABORATORIES, 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:

RUGBY LABORATORIES.

Indianapolis, IN 46268

PRINCIPAL DISPLAY PANEL

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: 0536-1394
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: 0536-1394-26	3 in 1 CARTON	10/06/2023
1		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	11/30/2022

Labeler - RUGBY LABORATORIES (079246066)

Establishment
Name	Address	ID/FEI	Business Operations
Dr.Reddy's Laboratories Limited (FTO III)		918608162	analysis(0536-1394) , manufacture(0536-1394)