Loratadine with Pseudoephedrine Tablet Technical Specification:
| Product Name: | Pseudoephedrine Sulfate 120mg/Loratadine 5mg Extended Release Tablets |
| Brand Name: | Generic |
| Strength: | 120mg+5mg, 240mg+10mg |
| Dosage Form: | Tablets (Film-coated tablet) |
| Route of Administration: | Via Oral Route |
| Packing: | 14s, 24s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Documents: | COA, MOA, Stability Studies, GMP, DMF, FSC, COPP and CTD Dossier |
| Therapeutic use: | Anti-histamine /Nasal Decongestant |
| Indication: | Loratadine is an antihistamine which provides relief of seasonal allergy symptoms such as watery and itching eyes, runny nose, and sneezing. Pseudoephedrine is a decongestant which helps relieve a stuffy nose, promotes sinus draining, and improves breathing. |
| Storage: | Store between 20℃ to 25℃ (68 °F to 77°F).Keep in dry place. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Loratadine 5mg with Pseudoephedrine Sulfate 120mg Tablet
Loratadine 10mg with Pseudoephedrine Sulfate 240mg Tablet
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each extended release tablet contains:
Loratadine USP ………………5mg
Pseudoephedrine Sulfate USP…………….120mg
THERAPEUTIC INDICATIONS:
Loratadine is an antihistamine which provides relief of seasonal allergy symptoms such as watery and itching eyes, runny nose, and sneezing. Pseudoephedrine is a decongestant which helps relieve a stuffy nose, promotes sinus draining, and improves breathing.
CAUTION & WARNING:
Do not use if carton is opened or if the blister unit is broken.
Do not exceed the stated dose.
Please read the enclosed leaflet before taking medicine.
Taking more than directed cause drowsiness.
Keep out of reach of children.
Do not break or chew; swallowed tablet whole.
An allergic reaction to these medicine occur, seek medical help right away
Symptoms do not improve by the 7 days or accompanied by fever.
If pregnant or breast feeding, ask health profession for the oral use.
In case over dose get medical help
Nervousness, dizziness and sleepiness occur
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 77°F).Keep in dry place.
Dosage: As directed by the Physician.