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Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride

Dosage form
TABLET, EXTENDED RELEASE
Labeler
PUBLIX SUPER MARKETS, INC
Label updated
2024-10-10
Retrieved
2026-09-07
Active ingredients
FEXOFENADINE HYDROCHLORIDE · PSEUDOEPHEDRINE HYDROCHLORIDE
View original label and images on DailyMed ↗
Label information

Drug Facts

Active ingredients (in each extended-release 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)

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

Label information

If pregnant or breast feeding, ask a health professional before use.

In case of overdose, get medical help or contact a Poison Control Center right away (1800-222-1222)

Label information

Keep Out of Reach of Children.

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
  • do not use if carton is opened or if individual blister units are torn or opened
  • store between 68° to 77°F (20° to 25 °C)
  • Meets dissolution test 6
Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, ethyl cellulose, ferric oxide yellow, hypromellose, lactose monohydrate, magnesuim stearate, microcrystalline cellulose, polyethylene glycol, povidone, stearic acid.

Label information

DISTRIBUTED BY
PUBLIX SUPER MARKETS, INC.,
3300 PUBLIX CORPORATE PARKWAY
LAKELAND, FL 33811

PRINCIPAL DISPLAY PANEL - 20 Tablet Blister Pack Carton

NDC 41415-995-20

12-HOUR • NON-DROWSY

allergyreliefD

FEXOFENADINE HCl 60 mg/ANTIHISTAMINE
PSEUDOEPHEDRINE HCl 120 mg/NASAL DECONGESTANT
EXTENDED-RELEASE TABLETS, USP

ORIGINAL PRESCRIPTION STRENGTH
ALLERGY & CONGESTION

12-hour relief of:
• Nasal and sinus congestion due to colds or allergies
• Sneezing • Runny nose • Itchy, watery eyes
• Itchy throat or nose due to allergies

INDOOR AND OUTDOOR ALLERGIES

20
EXTENDED-RELEASE
TABLETS

ACTUAL SIZE

*Compare to the active
ingredients of Allegra-D®

Do not use if individual blister unit is open or torn.

[Image in the official label — see DailyMed source]

PRINCIPAL DISPLAY PANEL - 30 Tablet Blister Pack Carton

NDC 41415-995-30

12-HOUR • NON-DROWSY

allergyreliefD

FEXOFENADINE HCl 60 mg/ANTIHISTAMINE
PSEUDOEPHEDRINE HCl 120 mg/NASAL DECONGESTANT
EXTENDED-RELEASE TABLETS, USP

ORIGINAL PRESCRIPTION STRENGTH
ALLERGY & CONGESTION

12-hour relief of:
• Nasal and sinus congestion due to colds or allergies
• Sneezing • Runny nose • Itchy, watery eyes
• Itchy throat or nose due to allergies

INDOOR AND OUTDOOR ALLERGIES

30
EXTENDED-RELEASE
TABLETS

ACTUAL SIZE

*Compare to the active
ingredients of Allegra-D®

Do not use if individual blister unit is open or torn.

[Image in the official label — see DailyMed source]

DailyMed Set ID: 75236b23-af51-40b6-ad1b-f62a27093a16 · Version 3
NDC: 41415-995