FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI- fexofenadine hcl and pseudoephedrine hci tablet, extended release 
Safeway Inc

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Fexofenadine HCl and Pseudoephedrine HCI ER Tablets USP 180240 mg

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

  • 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

Pregnancy/Breastfeeding

ask a health professional before use.

Keep out of reach of children

In case of overdose, get medical help or contacta 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

Storage

store between 20° - 25°C (68° - 77°F)

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 or comments?

call toll-free 1-888-375-3784

Manufactured by:

Dr. Reddy’s Laboratories Limited

Bachepalli - 502 325 INDIA.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

Blister carton label : 10's

carton

FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI 
fexofenadine hcl and pseudoephedrine hci tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-557(NDC:55111-557)
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
ACETYLTRIBUTYL CITRATE (UNII: 0ZBX0N59RZ)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)  
COPOVIDONE (UNII: D9C330MD8B)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYDROGENATED COTTONSEED OIL (UNII: Z82Y2C65EA)  
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULESize21mm
FlavorImprint Code RDY;572
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:21130-557-352 in 1 CARTON
15 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07904302/05/2013
Labeler - Safeway Inc (009137209)

Revised: 2/2014
Document Id: dfda3c7c-4c57-5917-ab77-7b5372ec14d2
Set id: 65a92250-d0e8-c902-b14c-67f53ab26635
Version: 1
Effective Time: 20140204
 
Safeway Inc