Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Tablets Technical Specification:
| Product Name: | Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Extended Release Tablets USP |
| Brand Name: | Generic |
| Strength: | 5mg+120mg |
| Dosage Form: | Tablets (Film-coated tablet) |
| Route of Administration: | Via Oral Route |
| Packing: | 14s, 24s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Documents: | COA, MOA, Stability Studies, GMP, DMF, FSC, COPP and CTD Dossier |
| Therapeutic use: | Anti-histamine /Nasal Decongestant |
| Indication: | Cetirizine Dihydrochloride and Pseudoephedrine hydrochloride Tablets is used to treat or prevent symptoms of allergies. It reduces congestion, sneezing, runny nose, and itching in the nose or throat. It also helps relieve itchy, watery, and red eyes. |
| Storage: | Store between 20℃ to 25℃ (68 °F to 77°F). |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Cetirizine Hydrochloride 5mg and 120mg Pseudoephedrine Hydrochloride Tablets
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each Extended release tablet contains:
Cetirizine HCl USP………………5mg
Pseudoephedrine HCl USP…………….120mg
THERAPEUTIC INDICATIONS:
Cetirizine Dihydrochloride and Pseudoephedrine hydrochloride Tablets is used to treat or prevent symptoms of allergies. It reduces congestion, sneezing, runny nose, and itching in the nose or throat. It also helps relieve itchy, watery, and red eyes.
CAUTION & WARNING:
Do not use if carton is opened or if the blister unit is broken.
Ask a doctor or Pharmacist before use if you are taking tranquilizer or sedatives.
Do not exceed the stated dose.
Please read the enclosed leaflet before taking medicine.
Keep out of reach of children.
Do not break or chew; swallowed tablet whole.
See side panel for lot number and expiration date.
WARNING: 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 how taking prescription monoamine oxidase inhibitor(MOA) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease). or 2 weeks after stopping MOA drug. if you do not know if your prescription drug contains an MOA, ask a doctor or pharmacist before taking this product.
DIRECTION OF USE:
| Adult and children 12 years and over | Take 1 tablet every 12 hours, do not take more than 2 tablets in 24 hours. |
| Children under 12 year of age | Ask doctor |
| Consumers with liver or kidney disease | Ask doctor |
STORAGE & DOSAGE:
Storage: Store between 20℃ to 25℃ (68 °F to 66 °F).
Dosage: As directed by the Physician.