Fexofenadine Hydrochloride And Pseudoephedrine Hydrochloride

Fexofenadine Hydrochloride And Pseudoephedrine Hydrochloride
SPL v3
SPL
SPL Set ID 45d3ad69-a80a-4f91-9c9b-8b19a30144a3
Route
ORAL
Published
Effective Date 2024-04-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fexofenadine (60 mg) Pseudoephedrine (120 mg)
Inactive Ingredients
Lactose Monohydrate Microcrystalline Cellulose Croscarmellose Sodium Povidone K30 Magnesium Stearate Dibasic Calcium Phosphate Dihydrate Silicon Dioxide Ethylcellulose, Unspecified Ferric Oxide Yellow Stearic Acid Hypromellose, Unspecified Polyethylene Glycol, Unspecified

Identifiers & Packaging

Pill Appearance
Imprint: 724 Shape: oval Color: white Color: yellow Size: 17 mm Score: 1
Marketing Status
ANDA Active Since 2020-08-27
Description

Drug Facts

Medication Information

Description

Drug Facts

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
Section 42229-5

Drug Facts

Section 50565-1

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

Section 53414-9

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

Section 55105-1
Active ingredients (in each extended-release tablet) Purpose
Fexofenadine HCl USP, 60 mg Antihistamine
Pseudoephedrine HCl USP, 120 mg Nasal Decongestant
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
Other Information
  • 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)
  • Meets dissolution test 6
Inactive Ingredients

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

Questions Or Comments?

Call toll-free 1-800-818-4555 weekdays

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
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.
Principal Display Panel 30 Tablet Blister Pack Carton

CVSHealth®

Compare to the active ingredients in Allegra-D®*

Indoor & Outdoor Allergies

NDC 69842-973-30

Non-Drowsy

ALLERGY & CONGESTION RELIEF

Allergy Relief D

FEXOFENADINE HCl 60 mg/Antihistamine

PSEUDOEPHEDRINE HCl 120 mg/Nasal decongestant

EXTENDED-RELEASE TABLETS, USP

12

HOUR

12 Hour Relief of:

  • Nasal & sinus congestion due to

    colds or allergies
  • Sneezing; Runny nose; Itchy, watery eyes

    & Itchy nose or throat due to allergies

DO NOT USE IF INDIVIDUAL

BLISTER UNIT IS OPEN OR TORN

30 EXTENDED-RELEASE TABLETS

Actual Size

Structured Label Content

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
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)
Active ingredients (in each extended-release tablet) Purpose
Fexofenadine HCl USP, 60 mg Antihistamine
Pseudoephedrine HCl USP, 120 mg Nasal Decongestant
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
Other Information (Other information)
  • 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)
  • Meets dissolution test 6
Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

Call toll-free 1-800-818-4555 weekdays

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)
Stop Use and Ask A Doctor If (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
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.
Principal Display Panel 30 Tablet Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 30 Tablet Blister Pack Carton)

CVSHealth®

Compare to the active ingredients in Allegra-D®*

Indoor & Outdoor Allergies

NDC 69842-973-30

Non-Drowsy

ALLERGY & CONGESTION RELIEF

Allergy Relief D

FEXOFENADINE HCl 60 mg/Antihistamine

PSEUDOEPHEDRINE HCl 120 mg/Nasal decongestant

EXTENDED-RELEASE TABLETS, USP

12

HOUR

12 Hour Relief of:

  • Nasal & sinus congestion due to

    colds or allergies
  • Sneezing; Runny nose; Itchy, watery eyes

    & Itchy nose or throat due to allergies

DO NOT USE IF INDIVIDUAL

BLISTER UNIT IS OPEN OR TORN

30 EXTENDED-RELEASE TABLETS

Actual Size

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:03:00.895658 · Updated: 2026-03-14T23:02:51.977564