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

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

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 20 Tablet Blister Pack Carton

^†Compare To

the active ingredients of

Allegra-D ^®

NDC 51660-037-21

ohm ^®

NON-DROWSY

Original Prescription Strength

Fexofenadine HCl 60 mg/Antihistamine

Pseudoephedrine HCl 120 mg/Nasal Decongestant

Extended-Release Tablets, USP

Allergy & Congestion

Indoor and Outdoor Allergies

DO NOT USE IF INDIVIDUAL BLISTER UNIT IS OPEN OR TORN

12 Hour

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)

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 20 Tablet Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 20 Tablet Blister Pack Carton)

^†Compare To

the active ingredients of

Allegra-D ^®

NDC 51660-037-21

ohm ^®

NON-DROWSY

Original Prescription Strength

Fexofenadine HCl 60 mg/Antihistamine

Pseudoephedrine HCl 120 mg/Nasal Decongestant

Extended-Release Tablets, USP

Allergy & Congestion

Indoor and Outdoor Allergies

DO NOT USE IF INDIVIDUAL BLISTER UNIT IS OPEN OR TORN

12 Hour

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

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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. In case of overdose, get medical help or contact a Poison Control Center right away (1800-222-1222).", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "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 - 20 Tablet Blister Pack Carton": "† Compare To the active ingredients of Allegra-D ® NDC 51660-037-21 ohm ® NON-DROWSY Original Prescription Strength Fexofenadine HCl 60 mg/Antihistamine Pseudoephedrine HCl 120 mg/Nasal Decongestant Extended-Release Tablets, USP Allergy & Congestion Indoor and Outdoor Allergies DO NOT USE IF INDIVIDUAL BLISTER UNIT IS OPEN OR TORN 12 Hour 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"}

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

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information