Fexofenadine Hydrochloride And Pseudoephedrine Hydrochloride Extended-release Tablets Usp, 60 Mg/120 Mg

Fexofenadine Hydrochloride And Pseudoephedrine Hydrochloride Extended-release Tablets Usp, 60 Mg/120 Mg
SPL v4
SPL
SPL Set ID ac67476a-2888-53c4-0a10-7f73ac2580c5
Route
ORAL
Published
Effective Date 2022-12-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fexofenadine (60 mg) Pseudoephedrine (120 mg)
Inactive Ingredients
Microcrystalline Cellulose 101 Croscarmellose Sodium Ferric Oxide Yellow Silicon Dioxide Magnesium Stearate Polyethylene Glycol 400 Hypromellose 2208 (100000 Mpa.s) Hydroxypropyl Cellulose (45000 Wamw) Hypromellose 2910 (6 Mpa.s) Polyethylene Glycol 8000 Starch, Corn Microcrystalline Cellulose 102

Identifiers & Packaging

Marketing Status
ANDA Active Since 2022-03-31
Description

Fexofenadine HCl USP, 60 mg Pseudoephedrine HCl USP, 120 mg

Purpose

Antihistamine Nasal decongestant

Medication Information

Purpose

Antihistamine

Nasal decongestant

Description

Fexofenadine HCl USP, 60 mg Pseudoephedrine HCl USP, 120 mg

Use(s)
  • 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 relives 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

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

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
Questions?

Call 1-888-375-3784

Other Information
  • safety sealed: do not use if carton is opened or if individual blister units are torn or opened
  • store between 20° to 25°C (68° to 77°F) store between 20° to 25°C (68° to 77°F)
  • FDA approved dissolution test specifications differ from USP.
  • FDA approved organic impurities test procedure differs from USP Procedure 1.
Active Ingredient(s)

Fexofenadine HCl USP, 60 mg

Pseudoephedrine HCl USP, 120 mg

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.

Principal Display Panel

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.

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.

Structured Label Content

Use(s)
  • 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 relives 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
Purpose

Antihistamine

Nasal decongestant

Warnings

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

Do Not Use (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
Questions?

Call 1-888-375-3784

Other Information (Other information)
  • safety sealed: do not use if carton is opened or if individual blister units are torn or opened
  • store between 20° to 25°C (68° to 77°F) store between 20° to 25°C (68° to 77°F)
  • FDA approved dissolution test specifications differ from USP.
  • FDA approved organic impurities test procedure differs from USP Procedure 1.
Active Ingredient(s) (Active ingredient(s))

Fexofenadine HCl USP, 60 mg

Pseudoephedrine HCl USP, 120 mg

Inactive Ingredients (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.

Principal Display Panel

When Using This Product (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 (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 (If pregnant or breast-feeding)

ask a health professional before use.

Keep Out of Reach of Children (Keep out of reach of children)

In case of overdose, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have (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.

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:39.709971 · Updated: 2026-03-14T23:11:22.461750