Fexofenadine Hydrochloride And Pseudoephedrine Hydrochloride

Drug Facts

Composition & Product

Active Ingredients

Fexofenadine (60 mg) Pseudoephedrine (120 mg)

Inactive Ingredients

Lactose Monohydrate Microcrystalline Cellulose Croscarmellose Sodium Povidone, Unspecified 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 Size: 17 mm Score: 1

Marketing Status

ANDA Active Since 2021-11-08

Medication Information

Purpose

Antihistamine

Nasal Decongestant

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.

Section 53414-9

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)

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 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.

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.

Active Ingredients (in Each Extended Release Tablet)

Fexofenadine HCl, USP 60 mg

Pseudoephedrine HCl, USP 120 mg

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.

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.

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.

Section 53414-9 (53414-9)

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)

Purpose

Antihistamine

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 68° to 77°F (20° to 25 °C)
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, magnesuim stearate, microcrystalline cellulose, polyethylene glycol, povidone, stearic acid.

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.

Active Ingredients (in Each Extended Release Tablet) (Active ingredients (in each extended-release tablet))

Fexofenadine HCl, USP 60 mg

Pseudoephedrine HCl, USP 120 mg

Principal Display Panel 20 Tablet Blister Pack Carton (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.

Principal Display Panel 30 Tablet Blister Pack Carton (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.

Advanced Ingredient Data

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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": "Drug Facts", "50565-1": "Keep Out of Reach of Children.", "53414-9": "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)", "Purpose": "Antihistamine 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 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.", "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.", "Active ingredients (in each extended-release tablet)": "Fexofenadine HCl, USP 60 mg Pseudoephedrine HCl, USP 120 mg", "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.", "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."}

Fexofenadine Hydrochloride And Pseudoephedrine Hydrochloride

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information