Fexofenadine Hcl 180 Mg And Pseudoephedrine Hci 240 Mg Er Tablets, Usp

Fexofenadine Hcl 180 Mg And Pseudoephedrine Hci 240 Mg Er Tablets, Usp
SPL v4
SPL
SPL Set ID 883d21cd-4c5f-b502-1465-e346ecc2e2ec
Route
ORAL
Published
Effective Date 2021-11-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fexofenadine (180 mg) Pseudoephedrine (240 mg)
Inactive Ingredients
Acetone Croscarmellose Sodium Cellulose Acetate Copovidone Hypromelloses Cellulose, Microcrystalline Polyethylene Glycol, Unspecified Talc Titanium Dioxide Isopropyl Alcohol Fd&c Blue No. 1 Aluminum Lake Magnesium Stearate Water Sodium Chloride Ferric Oxide Red Povidone K30 Ferrosoferric Oxide Propylene Glycol Silicon Dioxide

Identifiers & Packaging

Marketing Status
ANDA Completed Since 2022-11-30 Until 2026-08-31
Description

Fexofenadine HCl USP, 180 mg Pseudoephedrine HCl USP, 240 mg

Purpose

Antihistamine Nasal decongestant

Medication Information

Purpose

Antihistamine

Nasal decongestant

Description

Fexofenadine HCl USP, 180 mg Pseudoephedrine HCl USP, 240 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 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
Section 51945-4

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 24 hours on an empty stomach; do not take more than 1 tablet 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?

Questions? Call 1-888-287-1915 Weekdays (8am - 8pm EST)

Distributed by:

Walmart Inc.,

Bentonville, AR 72716

Other Information
  • each tablet contains: 28 mg sodium
  • safety sealed: do not use if carton is opened or if individual blister units are torn or opened
  • store between 20° - 25°C (68° - 77°F)
  • FDA approved dissolution test specifications differ from USP
Active Ingredient(s)

Fexofenadine HCl USP, 180 mg

Pseudoephedrine HCl USP, 240 mg

Inactive Ingredients

acetone, black iron oxide, cellulose acetate, colloidal silicon dioxide, copovidone, croscarmellose sodium, FD&C blue #1 aluminum lake, hypromellose, isopropyl alcohol, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, propylene glycol, red iron oxide, sodium chloride, talc, titanium dioxide, water

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
Keep Out of Reach of Children

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

If Pregnant Or Breast Feeding,

ask a health professional before use.

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 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
Section 51945-4 (51945-4)

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 24 hours on an empty stomach; do not take more than 1 tablet 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?

Questions? Call 1-888-287-1915 Weekdays (8am - 8pm EST)

Distributed by:

Walmart Inc.,

Bentonville, AR 72716

Other Information (Other information)
  • each tablet contains: 28 mg sodium
  • safety sealed: do not use if carton is opened or if individual blister units are torn or opened
  • store between 20° - 25°C (68° - 77°F)
  • FDA approved dissolution test specifications differ from USP
Active Ingredient(s) (Active ingredient(s))

Fexofenadine HCl USP, 180 mg

Pseudoephedrine HCl USP, 240 mg

Inactive Ingredients (Inactive ingredients)

acetone, black iron oxide, cellulose acetate, colloidal silicon dioxide, copovidone, croscarmellose sodium, FD&C blue #1 aluminum lake, hypromellose, isopropyl alcohol, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, propylene glycol, red iron oxide, sodium chloride, talc, titanium dioxide, water

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
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.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:35.833284 · Updated: 2026-03-14T23:09:28.158875