Active Ingredients And Purpose
Active ingredient (in each extended release tablet)
Cetirizine HCl 5 mg Pseudoephedrine HCl 120 mg
Purpose
Antihistamine Nasal Decongestant
Perrigo Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Drug Facts
- Manufacturer
- Dispensing Solutions, Inc. | PSS World Medical, Inc.
- Effective date
- 2013-07-17
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-05-31 22:36:12
Key Label Information
Uses
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
Warnings
Warnings
Directions And Dosage
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
Other Label Information
Other information
• store between 20° to 25°C (68° to 77°F)
Inactive ingredients
colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, yellow iron oxide
Questions or comments?
1-800-719-9260
Principal Display Panel
Compare to Zyrtec-D® active ingredients Original Prescription Strength Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Extended Release Tablets, 5mg/120mg Antihistamine/Nasal Decongestant Allergy & Congestion 12 Hour Relief of: Sneezing Itchy, Watery Eyes Runny Nose Itchy Throat or Nose Sinus Pressure Nasal Congestion Indoor & Outdoor Allergies Actual Size NDC 68258-8907-02
Products
- Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride
- Cetirizine HCl, Pseudoephedrine HCl
- CETIRIZINE
- PSEUDOEPHEDRINE
NDC Codes
Ingredients
Complete SPL Sections
Active ingredient (in each extended release tablet)
Cetirizine HCl 5 mg Pseudoephedrine HCl 120 mg
Purpose
Antihistamine Nasal Decongestant
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
Warnings
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
Other information
• store between 20° to 25°C (68° to 77°F)
Inactive ingredients
colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, yellow iron oxide
Questions or comments?
1-800-719-9260
Principal Display Panel
Compare to Zyrtec-D® active ingredients Original Prescription Strength Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Extended Release Tablets, 5mg/120mg Antihistamine/Nasal Decongestant Allergy & Congestion 12 Hour Relief of: Sneezing Itchy, Watery Eyes Runny Nose Itchy Throat or Nose Sinus Pressure Nasal Congestion Indoor & Outdoor Allergies Actual Size NDC 68258-8907-02
Source Document
Official SPL XML cached by FDA.report · DailyMed PDF
- XML object
- dailymed/89d33c73-ad56-43e1-b1a8-8bd98699c31d/2f0453e0-6c62-4ee0-94d8-5c354adb562d.xml
- XML SHA-256
- 6ad25e2e0004854699a69b0ebb8a2bc4298655550dcd91e5255af154d5e5d43c
- XML bytes
- 30956
Legacy File Index
| Folder | File | Date |
|---|---|---|
| otc | 2f0453e0-6c62-4ee0-94d8-5c354adb562d.xml | 2013-07-18 |
| otc | NDC 68258-8907-02------PERRIGO.jpg | 2013-07-18 |