FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCL- fexofenadine hcl and pseudoephedrine hcl tablet, extended release 
CVS Pharmacy, Inc

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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)

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

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

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

FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCL 
fexofenadine hcl and pseudoephedrine hcl tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-018
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
ColorWHITEScoreno score
ShapeROUNDSize12mm
FlavorImprint Code 892
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51316-018-102 in 1 CARTON11/30/2022
15 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:51316-018-153 in 1 CARTON11/30/2022
25 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07904311/30/2022
Labeler - CVS Pharmacy, Inc (062312574)
Establishment
NameAddressID/FEIBusiness Operations
Dr.Reddy's Laboratories Limited (FTO III)918608162analysis(51316-018) , manufacture(51316-018)

Revised: 1/2024
Document Id: b4188d3b-09b1-37df-badd-65dd93a9dc04
Set id: 3a878985-3a0e-1960-db0e-e3b8fd9d5c63
Version: 3
Effective Time: 20240128
 
CVS Pharmacy, Inc