Fexofenadine Hydrochloride And Pseudoephedrine Hydrochloride Extended-release Tablets Usp

Drug Facts

Composition & Product

Active Ingredients

Fexofenadine (60 mg) Pseudoephedrine (120 mg)

Inactive Ingredients

Silicon Dioxide Croscarmellose Sodium Ferric Oxide Yellow Hypromellose 2208 (100000 Mpa.s) Microcrystalline Cellulose Lactose Monohydrate Hydroxypropyl Cellulose (110000 Wamw) Polyethylene Glycol 6000 Polyethylene Glycol 400 Starch, Corn Stearic Acid

Identifiers & Packaging

Pill Appearance

Imprint: Z;79 Shape: capsule Color: yellow Size: 19 mm Score: 1

Marketing Status

ANDA Active Since 2024-05-17

Medication Information

Purpose

Antihistamine

Nasal decongestant

Description

Active ingredients (in each 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 53414-9

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

Warnings

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

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

Other information

safety sealed: do not use if carton is opened or if individual blister units are torn or opened.
store at 20-25°C (68-77°F).
Meets USP dissolution test 7

Drug Facts

Active ingredients (in each tablet)

Fexofenadine HCl USP 60 mg

Pseudoephedrine HCl USP 120 mg

Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, ferric oxide yellow, hydroxypropyl cellulose, hypromellose, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch (maize), stearic acid

Questions or Comments?

call 1-855-274-4122

IMPORTANT: Read the directions and warnings before use. Keep the carton, it contains important information.

Distributed by:

RUGBY^® LABORATORIES

Indianapolis, IN 46268

(800) 616-2471

Made in India

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 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

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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.

Package Label Principal Display Panel 2 X 10 Blister Carton

Rugby^®

Non-Drowsy

NDC 0536-1431-34

Compare to the active ingredients in

Allegra-D^® 12 Hour

Allergy & Congestion Tablets^*

Allergy & Congestion

Fexofenadine HCl and Pseudoephedrine HCl

Extended-Release Tablets, USP

60 mg/120 mg

Antihistamine and Nasal Decongestant

12 Hour

Indoor / Outdoor 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 53414-9 (53414-9)

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

Purpose

Antihistamine

Nasal decongestant

Warnings

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

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

Other information

safety sealed: do not use if carton is opened or if individual blister units are torn or opened.
store at 20-25°C (68-77°F).
Meets USP dissolution test 7

Drug Facts

Active ingredients (in each tablet)

Fexofenadine HCl USP 60 mg

Pseudoephedrine HCl USP 120 mg

Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, croscarmellose sodium, ferric oxide yellow, hydroxypropyl cellulose, hypromellose, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch (maize), stearic acid

Questions or Comments?

call 1-855-274-4122

IMPORTANT: Read the directions and warnings before use. Keep the carton, it contains important information.

Distributed by:

RUGBY^® LABORATORIES

Indianapolis, IN 46268

(800) 616-2471

Made in India

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 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

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 (1-800-222-1222) 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.

Package Label Principal Display Panel 2 X 10 Blister Carton (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2 x 10 Blister Carton)

Rugby^®

Non-Drowsy

NDC 0536-1431-34

Compare to the active ingredients in

Allegra-D^® 12 Hour

Allergy & Congestion Tablets^*

Allergy & Congestion

Fexofenadine HCl and Pseudoephedrine HCl

Extended-Release Tablets, USP

60 mg/120 mg

Antihistamine and Nasal Decongestant

12 Hour

Indoor / Outdoor 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", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "Purpose": "Antihistamine Nasal decongestant", "Warnings": "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", "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 Other information safety sealed: do not use if carton is opened or if individual blister units are torn or opened. store at 20-25°C (68-77°F). Meets USP dissolution test 7", "Drug Facts": "Active ingredients (in each tablet) Fexofenadine HCl USP 60 mg Pseudoephedrine HCl USP 120 mg", "Inactive ingredients": "colloidal silicon dioxide, croscarmellose sodium, ferric oxide yellow, hydroxypropyl cellulose, hypromellose, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch (maize), stearic acid Questions or Comments? call 1-855-274-4122 IMPORTANT: Read the directions and warnings before use. Keep the carton, it contains important information. Distributed by: RUGBY ® LABORATORIES Indianapolis, IN 46268 (800) 616-2471 Made in India", "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 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", "Keep out of reach of children.": "In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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.", "PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2 x 10 Blister Carton": "Rugby ® Non-Drowsy NDC 0536-1431-34 Compare to the active ingredients in Allegra-D ® 12 Hour Allergy & Congestion Tablets * Allergy & Congestion Fexofenadine HCl and Pseudoephedrine HCl Extended-Release Tablets, USP 60 mg/120 mg Antihistamine and Nasal Decongestant 12 Hour Indoor / Outdoor 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 Usp

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information