Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets USP

Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride by

Drug Labeling and Warnings

Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride by is a Otc medication manufactured, distributed, or labeled by McKESSON Corporation, Aurohealth LLC, Aurobindo Pharma Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE - fexofenadine hydrochloride and pseudoephedrine hydrochloride tablet, film coated, extended release 
Strategic Sourcing Services LLC

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Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets USP

Drug Facts

Active ingredients (in each tablet)

Fexofenadine HCl USP 60 mg
Pseudoephedrine HCl USP 120 mg

Purpose

Antihistamine
Nasal decongestant

Uses

  • 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 a 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 (1-800-222-1222) 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 12 hours on an empty stomach; do not take more than 2 tablets 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

  • safety sealed: do not use if carton is opened or if individual blister units are torn or opened. 
  • store at 20-25°C (68-77°F).
  • USP Dissolution Test Pending.

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, ferric oxide yellow, hydroxypropyl cellulose, hypromellose, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch (maize), stearic acid

Questions or Comments?

call 1-855-274-4122

IMPORTANT: Read the directions and warnings before use. Keep the carton, it contains important information.

Distributed by McKesson
One Post Street, San Francisco, CA 94104
Money Back Guarantee
healthmart.com

Made in India
 Code: TS/DRUGS/22/2009

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2 x 10 Blister Carton


NDC: 62011-0376-1

Compare to the active ingredients
in Allegra-D® 12 Hour
Allergy & Congestion Tablets

12 hour
Non-Drowsy


Health Mart®
Allergy & Congestion

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

Fexofenadine HCl 60 mg / antihistamine
Pseudoephedrine HCl 120 mg / nasal decongestion


indoor / outdoor relief of

  • nasal and sinus congestion due to colds or allergies
  • sneezing; runny nose; itchy, watery eyes and itchy nose or throat due to allergies    


20 extended release tablets
fexofenadine-fig1

FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE 
fexofenadine hydrochloride and pseudoephedrine hydrochloride tablet, film coated, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 62011-0376
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
HYPROMELLOSE 2208 (100000 MPA.S) (UNII: VM7F0B23ZI)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
HYDROXYPROPYL CELLULOSE (110000 WAMW) (UNII: 5Y0974F5PW)  
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorYELLOW (White to Off White Layer and Yellow to Pale Yellow) Scoreno score
ShapeCAPSULE (Bincovex) Size19mm
FlavorImprint Code Z;79
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 62011-0376-12 in 1 CARTON10/30/201712/10/2019
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20911610/30/201712/10/2019
Labeler - Strategic Sourcing Services LLC (116956644)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited650381903ANALYSIS(62011-0376) , MANUFACTURE(62011-0376)

Revised: 12/2019