26f2c3c1-a2f2-474a-950a-8cfe07f289fa
34390-5
Human OTC Drug Label
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Active ingredients (in each extended release tablet) Cetirizine HCl USP 5 mg Pseudoephedrine HCl USP 120 mg
Purpose
Antihistamine Nasal decongestant
Medication Information
Purpose
Antihistamine
Nasal decongestant
Description
Active ingredients (in each extended release tablet) Cetirizine HCl USP 5 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
- nasal congestion
- reduces swelling of nasal passages
- temporarily relieves sinus congestion and pressure
- temporarily restores freer breathing through the nose
Directions
- do not break or chew tablet; swallow tablet whole
| adults and children 12 years and over |
take 1 tablet every 12 hours; do not take more than 2 tablets in 24 hours. |
| adults 65 years and over |
ask a doctor |
| children under 12 years of age |
ask a doctor |
| consumers with liver or kidney disease |
ask a doctor |
Do Not Use
- if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.
- 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.
Drug Facts
Active ingredients (in each extended release tablet)
Cetirizine HCl USP 5 mg
Pseudoephedrine HCl USP 120 mg
Other Information
- store between 20° to 25°C (68° to 77°F)
- do not use if carton is opened or if individual blister units are torn or broken
Inactive Ingredients
colloidal silicon dioxide, croscarmellose sodium, ferric oxide, hypromellose, magnesium stearate, microcrystalline cellulose.
Questions or comments?
call 1-855-274-4122
(Monday - Friday 8:30 AM to 5:00 PM EST)
Distributed by: AUROHEALTH LLC
279 Princeton-Hightstown Road
East Windsor, NJ 08520
Made in India
Code: AP/DRUGS/04/2016
When Using This Product
- do not use more than directed
- drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
Stop Use and Ask A Doctor If
- an allergic reaction to this product occurs. Seek medical help right away.
- you get nervous, dizzy, or sleepless
- symptoms do not improve within 7 days or are accompanied by fever
If Pregnant Or Breast Feeding:
- if breast-feeding: not recommended
- if pregnant: 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. (1-800-222-1222)
Ask A Doctor Before Use If You Have
- heart disease
- thyroid disease
- diabetes
- glaucoma
- high blood pressure
- trouble urinating due to an enlarged prostate gland
- liver or kidney disease. Your doctor should determine if you need a different dose.
Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.
Package Label Principal Display Panel 5 Mg/120 Mg (12 X 2) Blister Carton
AUROHEALTH
NDC 58602-703-09
*Compare to the active
ingredients of Zyrtec-D®
Original Prescription Strength
Cetirizine Hydrochloride and
Pseudoephedrine Hydrochloride
Extended-Release Tablets, USP
5 mg/ 120 mg
Antihistamine/Nasal Decongestant
Indoor & Outdoor
Allergies
ALLERY + SINUS
NASAL CONGESTION + SINUS PRESSURE
12 Hour relief of
Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose
Actual Size
24
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
- nasal congestion
- reduces swelling of nasal passages
- temporarily relieves sinus congestion and pressure
- temporarily restores freer breathing through the nose
Purpose
Antihistamine
Nasal decongestant
Directions
- do not break or chew tablet; swallow tablet whole
| adults and children 12 years and over |
take 1 tablet every 12 hours; do not take more than 2 tablets in 24 hours. |
| adults 65 years and over |
ask a doctor |
| children under 12 years of age |
ask a doctor |
| consumers with liver or 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 or to an antihistamine containing hydroxyzine.
- 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.
Drug Facts
Active ingredients (in each extended release tablet)
Cetirizine HCl USP 5 mg
Pseudoephedrine HCl USP 120 mg
Other Information (Other information)
- store between 20° to 25°C (68° to 77°F)
- do not use if carton is opened or if individual blister units are torn or broken
Inactive Ingredients (Inactive ingredients)
colloidal silicon dioxide, croscarmellose sodium, ferric oxide, hypromellose, magnesium stearate, microcrystalline cellulose.
Questions or comments?
call 1-855-274-4122
(Monday - Friday 8:30 AM to 5:00 PM EST)
Distributed by: AUROHEALTH LLC
279 Princeton-Hightstown Road
East Windsor, NJ 08520
Made in India
Code: AP/DRUGS/04/2016
When Using This Product (When using this product)
- do not use more than directed
- drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
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.
- you get nervous, dizzy, or sleepless
- symptoms do not improve within 7 days or are accompanied by fever
If Pregnant Or Breast Feeding: (If pregnant or breast-feeding:)
- if breast-feeding: not recommended
- if pregnant: 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. (1-800-222-1222)
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
- heart disease
- thyroid disease
- diabetes
- glaucoma
- high blood pressure
- trouble urinating due to an enlarged prostate gland
- liver or kidney disease. Your doctor should determine if you need a different dose.
Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.
Package Label Principal Display Panel 5 Mg/120 Mg (12 X 2) Blister Carton (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -5 mg/120 mg (12 x 2) Blister Carton)
AUROHEALTH
NDC 58602-703-09
*Compare to the active
ingredients of Zyrtec-D®
Original Prescription Strength
Cetirizine Hydrochloride and
Pseudoephedrine Hydrochloride
Extended-Release Tablets, USP
5 mg/ 120 mg
Antihistamine/Nasal Decongestant
Indoor & Outdoor
Allergies
ALLERY + SINUS
NASAL CONGESTION + SINUS PRESSURE
12 Hour relief of
Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose
Actual Size
24
EXTENDED-RELEASE TABLETS
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
Back to search View SPL set listing Open on DailyMed ↗
Source: dailymed · Ingested: 2026-02-15T12:04:25.680435 · Updated: 2026-03-14T23:05:09.820545