Cetirizine Hydrochloride And Pseudoephedrine Hydrochloride Extended-release Tablets, Usp
796c4b81-145b-4050-a851-dec81ff97006
34390-5
Human OTC Drug Label
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Cetirizine HCl, USP 5 mg Pseudoephedrine HCl, USP 120 mg
Purpose
Antihistamine Nasal decongestant
Medication Information
Purpose
Antihistamine Nasal decongestant
Description
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
Purposes
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
- 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) (cer tain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks af ter 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.
Questions?
Call toll free 1-800-818-4555 weekdays
Other Information
- store between 20° to 25°C (68° to 77°F)
- Do not use if carton is opened or if the blister unit is broken
- See side panel for lot number and expiration date
Active Ingredients
Cetirizine HCl, USP 5 mg
Pseudoephedrine HCl, USP 120 mg
Inactive Ingredients
hydroxyethyl cellulose, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, stearic acid, titanium dioxide
Imprinting Ink Contents: ammonium hydroxide, iron oxide black, isopropyl alcohol, N-butyl alcohol, propylene glycol, shellac glaze
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).
Principal Display Panel Showbox
NDC 62756-915-62
Original Prescription Strength
Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Extended-release Tablets, USP
5 mg/120 mg
Antihistamine/Nasal Decongestant
Indoor & Outdoor Allergies
ALLERGY & SINUS
SUN PHARMA
Actual Size
DO NOT USE IF INDIVIDUAL BLISTER UNIT IS OPEN OR TORN
12 Tablets (2 blister cards of 6 tablets each)
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.
Principal Display Panel Blister Pack
Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablet, USP
5 mg/120 mg
Mfg. by: Sun Pharmaceutical Ind. Ltd. India.
Ask A Doctor Or Pharmacist Before Use If You Are
taking tranquilizers or sedatives.
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
Purposes
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) (cer tain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks af ter 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.
Questions?
Call toll free 1-800-818-4555 weekdays
Other Information (Other information)
- store between 20° to 25°C (68° to 77°F)
- Do not use if carton is opened or if the blister unit is broken
- See side panel for lot number and expiration date
Active Ingredients (Active ingredients)
Cetirizine HCl, USP 5 mg
Pseudoephedrine HCl, USP 120 mg
Inactive Ingredients (Inactive ingredients)
hydroxyethyl cellulose, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, stearic acid, titanium dioxide
Imprinting Ink Contents: ammonium hydroxide, iron oxide black, isopropyl alcohol, N-butyl alcohol, propylene glycol, shellac glaze
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).
Principal Display Panel Showbox (Principal Display Panel - Showbox)
NDC 62756-915-62
Original Prescription Strength
Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Extended-release Tablets, USP
5 mg/120 mg
Antihistamine/Nasal Decongestant
Indoor & Outdoor Allergies
ALLERGY & SINUS
SUN PHARMA
Actual Size
DO NOT USE IF INDIVIDUAL BLISTER UNIT IS OPEN OR TORN
12 Tablets (2 blister cards of 6 tablets each)
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.
Principal Display Panel Blister Pack (Principal Display Panel - Blister pack)
Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablet, USP
5 mg/120 mg
Mfg. by: Sun Pharmaceutical Ind. Ltd. India.
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
taking tranquilizers or sedatives.
Advanced Ingredient Data
Raw Label Data
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Source: dailymed · Ingested: 2026-02-15T12:04:33.794442 · Updated: 2026-03-14T23:05:23.931529