FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCL  24 HOUR- fexofenadine hcl and pseudoephedrine hcl tablet, extended release 
Cardinal Health

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Fexofenadine HCl 180 mg and Pseudoephedrine HCI 240 mg ER Tablets, USP

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 agedo not use
adults 65 years of age  and olderask a doctor
consumers with kidney diseaseask 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

carton

FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCL   24 HOUR
fexofenadine hcl and pseudoephedrine hcl tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0607
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) FEXOFENADINE HYDROCHLORIDE180 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE240 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITEScorescore with uneven pieces
ShapeROUNDSize12mm
FlavorImprint Code 892
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0607-12 in 1 CARTON05/16/2022
15 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07904305/16/2022
Labeler - Cardinal Health (063997360)
Establishment
NameAddressID/FEIBusiness Operations
Dr.Reddy's Laboratories Limited (FTO III)918608162analysis(70000-0607) , manufacture(70000-0607)

Revised: 4/2022
Document Id: 5ce1bb61-ffe3-38fe-18ef-99d50c0c058f
Set id: 3d79bfa5-ae6a-988f-6346-705a0ecaa82a
Version: 1
Effective Time: 20220428
 
Cardinal Health