Fexofenadine Hydrochloride And Pseudoephedrine Hydrochloride Extended-release Tablets, 60 Mg/120 Mg
8afc0167-17bf-4ccd-91c9-8fb9c4e241c1
34390-5
Human OTC Drug Label
Drug Facts
Composition & Product
Identifiers & Packaging
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
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)
- Meets dissolution test 6
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.
Principal Display Panel
NDC 47335-724-83
ORIGINAL PRESCRIPTION STRENGTH
NON-DROWSY
Fexofenadine HCl and Pseudoephedrine HCl Extended-Release Tablets, USP
60 mg/120 mg
ALLERGY &
CONGESTION
12 HR
Antihistamine/Nasal Decongestant
Indoor and Outdoor Allergies
30 Tablets
SUN PHARMA
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.
Principal Display Panel Showbox
NDC 47335-724-94
ORIGINAL PRESCRIPTION STRENGTH NON-DROWSY
Fexofenadine HCI and Pseudoephedrine HCI Extended-Release Tablets, USP
60 mg/120 mg
ALLERGY & CONGESTION
12 HR
Antihistamine/Nasal Decongestant
10 Extended-Release Tablets
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
DO NOT USE IF INDIVIDUAL BLISTER UNIT IS OPEN OR TORN
SUN PHARMA
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
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
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)
- Meets dissolution test 6
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)
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.
Principal Display Panel
NDC 47335-724-83
ORIGINAL PRESCRIPTION STRENGTH
NON-DROWSY
Fexofenadine HCl and Pseudoephedrine HCl Extended-Release Tablets, USP
60 mg/120 mg
ALLERGY &
CONGESTION
12 HR
Antihistamine/Nasal Decongestant
Indoor and Outdoor Allergies
30 Tablets
SUN PHARMA
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.
Principal Display Panel Showbox (Principal Display Panel-Showbox)
NDC 47335-724-94
ORIGINAL PRESCRIPTION STRENGTH NON-DROWSY
Fexofenadine HCI and Pseudoephedrine HCI Extended-Release Tablets, USP
60 mg/120 mg
ALLERGY & CONGESTION
12 HR
Antihistamine/Nasal Decongestant
10 Extended-Release Tablets
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
DO NOT USE IF INDIVIDUAL BLISTER UNIT IS OPEN OR TORN
SUN PHARMA
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.
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Raw Label Data
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Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:05:41.725850 · Updated: 2026-03-14T23:07:53.934759