Fexofenadine Hcl 60 Mg And Pseudoephedrine Hci 120 Mg Er Tablets Usp

SPL v2

SPL

SPL Set ID cb9e98a9-74e6-7a3e-9c5e-3bc35c4bbca6

Route

ORAL

Published

Effective Date 2015-07-30

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Fexofenadine (60 mg) Pseudoephedrine (120 mg)

Inactive Ingredients

Mannitol Powdered Cellulose Starch, Corn Croscarmellose Sodium Silicon Dioxide Ferric Oxide Red Magnesium Stearate Hypromelloses Triethyl Citrate

Identifiers & Packaging

Pill Appearance

Imprint: R;195 Shape: round Color: white Size: 7 mm Score: 1

Marketing Status

ANDA Active Since 2015-04-22

Description

Fexofenadine HCl USP, 60 mg Pseudoephedrine HCl USP,120 mg

Purpose

Antihistamine Nasal decongestant

Medication Information

Purpose

Antihistamine

Nasal decongestant

Description

Fexofenadine HCl USP, 60 mg Pseudoephedrine HCl USP,120 mg

Use(s)

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
runny nose
sneezing
nasal congestion
itchy, watery eyes
itching of the nose or throat
reduces swelling of nasal passages
temporarily relieves sinus congestion and pressure
temporarily restores freer breathing through the nose

Storage

store between 20° to 25°C (68° to 77°F)

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

Other Information

safety sealed: do not use if carton is opened or if individual blister units are torn or opened
this product meets the requirements of USP dissolution test 3.

Active Ingredient(s)

Fexofenadine HCl USP, 60 mg

Pseudoephedrine HCl USP,120 mg

Inactive Ingredients

corn starch, croscarmellose sodium, colloidal silicon dioxide, ferric oxide, hypromellose, kollidon SR, magnesium stearate, mannitol, powder cellulose, and triethyl citrate.

Questions Or Comments?

call toll-free 1-888-375-3784

Manufactured by:

Dr. Reddy’s Laboratories Limited

Bachupally - 500 090 INDIA

Pregnancy/breastfeeding

ask a health professional before use.

Principal Display Panel

Blister carton 20's (4x5 unit-dose)

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 takeas directed (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

Keep Out of Reach of Children

In case of overdose, get medical help or contacta 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.

Structured Label Content

Use(s)

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
runny nose
sneezing
nasal congestion
itchy, watery eyes
itching of the nose or throat
reduces swelling of nasal passages
temporarily relieves sinus congestion and pressure
temporarily restores freer breathing through the nose

Purpose

Antihistamine

Nasal decongestant

Storage

store between 20° to 25°C (68° to 77°F)

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

Other Information (Other information)

safety sealed: do not use if carton is opened or if individual blister units are torn or opened
this product meets the requirements of USP dissolution test 3.

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

Fexofenadine HCl USP, 60 mg

Pseudoephedrine HCl USP,120 mg

Inactive Ingredients (Inactive ingredients)

corn starch, croscarmellose sodium, colloidal silicon dioxide, ferric oxide, hypromellose, kollidon SR, magnesium stearate, mannitol, powder cellulose, and triethyl citrate.

Questions Or Comments? (Questions or comments?)

call toll-free 1-888-375-3784

Manufactured by:

Dr. Reddy’s Laboratories Limited

Bachupally - 500 090 INDIA

Pregnancy/breastfeeding (Pregnancy/Breastfeeding)

ask a health professional before use.

Principal Display Panel

Blister carton 20's (4x5 unit-dose)

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 takeas directed (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

Keep Out of Reach of Children (Keep out of reach of children)

In case of overdose, get medical help or contacta 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.

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Use(s)": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing nasal congestion itchy, watery eyes itching of the nose or throat reduces swelling of nasal passages temporarily relieves sinus congestion and pressure temporarily restores freer breathing through the nose", "Purpose": "Antihistamine Nasal decongestant", "Storage": "store between 20° to 25°C (68° to 77°F)", "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": "safety sealed: do not use if carton is opened or if individual blister units are torn or opened this product meets the requirements of USP dissolution test 3.", "Active ingredient(s)": "Fexofenadine HCl USP, 60 mg Pseudoephedrine HCl USP,120 mg", "Inactive ingredients": "corn starch, croscarmellose sodium, colloidal silicon dioxide, ferric oxide, hypromellose, kollidon SR, magnesium stearate, mannitol, powder cellulose, and triethyl citrate.", "Questions or comments?": "call toll-free 1-888-375-3784 Manufactured by: Dr. Reddy’s Laboratories Limited Bachupally - 500 090 INDIA", "Pregnancy/Breastfeeding": "ask a health professional before use.", "Principal Display Panel": "Blister carton 20's (4x5 unit-dose)", "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 takeas directed (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", "Keep out of reach of children": "In case of overdose, get medical help or contacta 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."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:27.270680 · Updated: 2026-03-14T22:54:56.160161