Fexofenadine Hydrochloride And Pseudoephedrine Hydrochloride Tablet, Film Coated, Extended Release
FDA Label NDC 51316-007

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy, Inc. for the product Fexofenadine Hydrochloride And Pseudoephedrine Hydrochloride (NDC 51316-007). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, purpose, uses, warnings, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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).
    • Meets USP dissolution test 7

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

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2023 CVS/pharmacy
CVS.com®  1-800-SHOP CVS

Made in India

Code: TS/DRUGS/22/2009

Package Label-Principal Display Panel - 2 X 10 Blister Carton

CVSHealth®

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

NDC 51316-007-67

Original Prescription Strength
ALLERGY & CONGESTION RELIRF
Allergy Relief D

Fexofenadine HCl  60 mg/ Antihistamine
PSEUDOEPHEDRINE HCI 120 mg / Nasal decongestant
EXTENDED-RELEASE TABLETS, USP

12
HOUR

INDOOR/OUTDOOR RELIEF OF:


•  Nasal & sinus congestion due to
    colds or allergies

•  Sneezing; Runny nose; Itchy, watery eyes 
    & Itchy nose or throat due to allergies    


Non-drowsy

20 EXTENDED-RELEASE TABLETS                  

Package Label-principal Display Panel (20 Blister Carton)

Package Label-principal Display Panel (20 Blister Carton)



* Please review the disclaimer below.