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

SPL v1

SPL

SPL Set ID c20f780c-562b-4eb6-940d-2973382118eb

Route

ORAL

Published

Effective Date 2018-05-31

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: capsule Color: white Color: yellow Size: 17 mm Score: 1

Marketing Status

ANDA Active Since 2018-03-01

Description

(in each extended-release tablet) Fexofenadine HCl, USP 60 mg Pseudoephedrine HCl, USP 120 mg

Purpose

Antihistamine Nasal Decongestant

Medication Information

Purpose

Antihistamine

Nasal Decongestant

Description

(in each extended-release tablet) Fexofenadine HCl, USP 60 mg Pseudoephedrine HCl, USP 120 mg

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

Distributed By AmerisourceBergen

1300 Morris Drive, Chesterbrook, PA 19087

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 toll free 1-800-818-4555 weekdays

Other Information

safety sealed; do not use if inner safety seal is open or torn
store between 20° to 25°C (68° to 77°F)
USP dissolution test is pending.

Active Ingredient(s)

(in each extended-release tablet)

Fexofenadine HCl, USP 60 mg

Pseudoephedrine HCl, USP 120 mg

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.

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 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.

Principal Display Panel 60 Mg/120 Mg Tablet Blister Pack Carton

GOOD

NEIGHBOR

PHARMACY^®

Compare to Allegra-D^® active ingredients**

NDC 46122-452-60

Original Prescription Strength

NON-DROWSY

12 HOUR

fexofenadine HCl 60 mg/antihistamine

pseudoephedrine HCl 120 mg/nasal decongestant

Extended-Release Tablets, USP

Indoor & Outdoor Allergies

Allergy & Congestion

Relief of:

Nasal and Sinus Congestion Due to Colds or Allergies
Sneezing; Runny Nose; Itchy, Watery Eyes and Itchy Nose or

Throat Due to Allergies

20 Extended-Release Tablets

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)

Distributed By AmerisourceBergen

1300 Morris Drive, Chesterbrook, PA 19087

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 toll free 1-800-818-4555 weekdays

Other Information (Other information)

safety sealed; do not use if inner safety seal is open or torn
store between 20° to 25°C (68° to 77°F)
USP dissolution test is pending.

Active Ingredient(s) (Active ingredient(s))

(in each extended-release tablet)

Fexofenadine HCl, USP 60 mg

Pseudoephedrine HCl, USP 120 mg

Inactive Ingredients (Inactive ingredients)

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 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.

Principal Display Panel 60 Mg/120 Mg Tablet Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 60 mg/120 mg Tablet Blister Pack Carton)

GOOD

NEIGHBOR

PHARMACY^®

Compare to Allegra-D^® active ingredients**

NDC 46122-452-60

Original Prescription Strength

NON-DROWSY

12 HOUR

fexofenadine HCl 60 mg/antihistamine

pseudoephedrine HCl 120 mg/nasal decongestant

Extended-Release Tablets, USP

Indoor & Outdoor Allergies

Allergy & Congestion

Relief of:

Nasal and Sinus Congestion Due to Colds or Allergies
Sneezing; Runny Nose; Itchy, Watery Eyes and Itchy Nose or

Throat Due to Allergies

20 Extended-Release Tablets

Advanced Ingredient Data

[{"name": "FEXOFENADINE", "unii": "E6582LOH6V", "classCode": "ACTIB", "strengthNumerator": "60", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "PSEUDOEPHEDRINE", "unii": "7CUC9DDI9F", "classCode": "ACTIB", "strengthNumerator": "120", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "LACTOSE MONOHYDRATE", "unii": "EWQ57Q8I5X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CROSCARMELLOSE SODIUM", "unii": "M28OL1HH48", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE K30", "unii": "U725QWY32X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIBASIC CALCIUM PHOSPHATE DIHYDRATE", "unii": "O7TSZ97GEP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ETHYLCELLULOSE, UNSPECIFIED", "unii": "7Z8S9VYZ4B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FERRIC OXIDE YELLOW", "unii": "EX438O2MRT", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE, UNSPECIFIED", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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", "42229-5": "Distributed By AmerisourceBergen 1300 Morris Drive, Chesterbrook, PA 19087", "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": "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 toll free 1-800-818-4555 weekdays", "Other information": "safety sealed; do not use if inner safety seal is open or torn store between 20° to 25°C (68° to 77°F) USP dissolution test is pending.", "Active ingredient(s)": "(in each extended-release tablet) Fexofenadine HCl, USP 60 mg Pseudoephedrine HCl, USP 120 mg", "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.", "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 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.", "PRINCIPAL DISPLAY PANEL - 60 mg/120 mg Tablet Blister Pack Carton": "GOOD NEIGHBOR PHARMACY ® Compare to Allegra-D ® active ingredients** NDC 46122-452-60 Original Prescription Strength NON-DROWSY 12 HOUR fexofenadine HCl 60 mg/antihistamine pseudoephedrine HCl 120 mg/nasal decongestant Extended-Release Tablets, USP Indoor & Outdoor Allergies Allergy & Congestion Relief of: Nasal and Sinus Congestion Due to Colds or Allergies Sneezing; Runny Nose; Itchy, Watery Eyes and Itchy Nose or Throat Due to Allergies 20 Extended-Release Tablets"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:34.826811 · Updated: 2026-03-14T22:55:08.159087