Cetirizine Hydrochloride And Pseudoephedrine Hydrochloride Extended-release Tablets, Usp
c24f3760-70e0-410f-bf80-6d0cadcd61b9
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Important: Read all product information before using. Keep this box for important information.
Medication Information
Description
Important: Read all product information before using. Keep this box for important information.
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
Section 42229-5
Important: Read all product information before using. Keep this box for important information.
Section 50565-1
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.
Section 50568-5
Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.
Section 55105-1
| Active ingredients (in each extended-release tablet) | Purposes |
|---|---|
| Cetirizine HCl, USP 5 mg | Antihistamine |
| Pseudoephedrine HCl, USP 120 mg | 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) (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.
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
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.
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 12 Tablet Blister Card Carton
†Compare To
the active ingredients of
Zyrtec-D®12Hr
NDC 51660-940-12
ohm®
12
Hour
Allergy Relief
Nasal Decongestant
Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride
Extended-Release Tablets, USP 5 mg/120 mg
Antihistamine/Nasal Decongestant
12 Hour Relief of:
• Sneezing • Itchy, Watery Eyes • Sinus Pressure
• Runny Nose • Itchy Throat or Nose
• Nasal Congestion
Indoor & Outdoor Allergies
ALLERGY & SINUS
12 Tablets (2 blister cards of 6 tablets each)
Original Prescription Strength
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
Section 42229-5 (42229-5)
Important: Read all product information before using. Keep this box for important information.
Section 50565-1 (50565-1)
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.
Section 50568-5 (50568-5)
Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.
Section 55105-1 (55105-1)
| Active ingredients (in each extended-release tablet) | Purposes |
|---|---|
| Cetirizine HCl, USP 5 mg | Antihistamine |
| Pseudoephedrine HCl, USP 120 mg | 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.
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
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.
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 12 Tablet Blister Card Carton (PRINCIPAL DISPLAY PANEL - 12 Tablet Blister Card Carton)
†Compare To
the active ingredients of
Zyrtec-D®12Hr
NDC 51660-940-12
ohm®
12
Hour
Allergy Relief
Nasal Decongestant
Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride
Extended-Release Tablets, USP 5 mg/120 mg
Antihistamine/Nasal Decongestant
12 Hour Relief of:
• Sneezing • Itchy, Watery Eyes • Sinus Pressure
• Runny Nose • Itchy Throat or Nose
• Nasal Congestion
Indoor & Outdoor Allergies
ALLERGY & SINUS
12 Tablets (2 blister cards of 6 tablets each)
Original Prescription Strength
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:05:10.257362 · Updated: 2026-03-14T23:06:34.860555