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Fexofenadine HCl and Pseudoephedrine HCI

Medically reviewed on December 7, 2017

Dosage form: tablet, extended release
Ingredients: FEXOFENADINE HYDROCHLORIDE 60mg, PSEUDOEPHEDRINE HYDROCHLORIDE 120mg
Labeler: The Kroger Co.
NDC Code: 30142-447

Fexofenadine HCl 60 mg and Pseudoephedrine HCI 120 mg ER Tablets USP

Active ingredient(s)

Fexofenadine HCl USP, 60 mg

Pseudoephedrine HCl USP,120 mg

Purpose

Antihistamine

Nasal decongestant

Use(s)
  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  • runny nose
  • sneezing
  • nasal congestion
  • itchy, watery eyes
  • itching of the nose or throat
  • 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 takeas 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
  • 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 agedo not use
Adults 65 years of age  and olderask a doctor
consumers with kidney diseaseask a doctor

Other information
  • safety sealed: do not use if carton is opened or if individual blister units are torn or opened
  • this product meets the requirements of USP dissolution test 3.

Storage
  • store between 20° to 25°C (68° to 77°F)

Inactive ingredients

corn starch, croscarmellose sodium, colloidal silicon dioxide, ferric oxide, hypromellose, kollidon SR, magnesium stearate, mannitol, powder cellulose, and triethyl citrate.

Questions or comments?

call toll-free 1-888-375-3784

Manufactured by:

Dr. Reddy’s Laboratories Limited

Bachupally - 500 090 INDIA

Principal Display Panel

Blister carton 20's (4x5 unit-dose)

FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI 
fexofenadine hcl and pseudoephedrine hci tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-447
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE) FEXOFENADINE HYDROCHLORIDE60 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE120 mg
Inactive Ingredients
Ingredient NameStrength
MANNITOL 
POWDERED CELLULOSE 
STARCH, CORN 
CROSCARMELLOSE SODIUM 
SILICON DIOXIDE 
FERRIC OXIDE RED 
MAGNESIUM STEARATE 
HYPROMELLOSES 
TRIETHYL CITRATE 
Product Characteristics
ColorWHITE (off white to pale yellow one layer and light red to red other layer) Scoreno score
ShapeROUNDSize7mm
FlavorImprint CodeR;195
Contains    
Packaging
#Item CodePackage Description
1NDC:30142-447-144 BLISTER PACK in 1 CARTON
15 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07666704/22/2015
Labeler - The Kroger Co. (006999528)

 
The Kroger Co.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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