FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE- fexofenadine hydrochloride and pseudoephedrine hydrochloride tablet, extended release 
RUGBY LABORATORIES

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Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets USP, 60 mg/120 mg

Active ingredient(s)

Fexofenadine HCl USP, 60 mg

Pseudoephedrine HCl USP, 120 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 12 hours on an empty stomach; do not take more than 2 tablets 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

colloidal silicon dioxide, croscarmellose sodium, ferric oxide (iron oxide yellow), HPMC 2910 / hypromellose (6 Cps), hydroxypropyl cellulose, hypromellose (methocel K100M DC2), macrogol (polyethylene glycol MW 400), macrogol (polyethylene glycol MW 8000), magnesium stearate, microcrystalline cellulose (avicel PH 101), microcrystalline cellulose (avicel PH102), pregelatinized starch.

Questions?

Call toll-free weekdays 9 AM to 8 PM EST Call 1-888-375-3784

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FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE 
fexofenadine hydrochloride and pseudoephedrine hydrochloride tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1384
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) FEXOFENADINE HYDROCHLORIDE60 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE120 mg
Inactive Ingredients
Ingredient NameStrength
MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)  
Croscarmellose Sodium (UNII: M28OL1HH48)  
Ferric Oxide Yellow (UNII: EX438O2MRT)  
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
Magnesium Stearate (UNII: 70097M6I30)  
Polyethylene Glycol 400 (UNII: B697894SGQ)  
Hypromellose 2208 (100000 Mpa.S) (UNII: VM7F0B23ZI)  
HYDROXYPROPYL CELLULOSE (45000 WAMW) (UNII: 8VAB711C5E)  
Hypromellose 2910 (6 Mpa.S) (UNII: 0WZ8WG20P6)  
Polyethylene Glycol 8000 (UNII: Q662QK8M3B)  
Starch, Corn (UNII: O8232NY3SJ)  
MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)  
Product Characteristics
ColorWHITE (one white to off-white color layer and other light yellow to yellow color) Scoreno score
ShapeCAPSULESize16mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-1384-076 in 1 CARTON05/19/2023
15 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:0536-1384-344 in 1 CARTON05/19/2023
25 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21543403/31/2022
Labeler - RUGBY LABORATORIES (079246066)

Revised: 5/2023
Document Id: 3e628c0e-311d-2ab0-8a9a-504f2b153f40
Set id: 79d46e48-1885-7fcb-b542-eea562406928
Version: 1
Effective Time: 20230519
 
RUGBY LABORATORIES