Paracetamol, Caffeine Anhydrous and Phenylephrine Hydrochloride Tablets Technical Specification:
| Product Name: | Paracetamol, Caffeine Anhydrous and Phenylephrine Hydrochloride Tablets |
| Brand Name: | Generic |
| Strength: | (325mg+32mg+10mg), (500mg+30mg+10mg), (500mg+32mg+ 10mg) |
| Dosage Form: | Tablets (Uncoated tablet) |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 12s, 15s, 16s, 100s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Pain reliever/ Analgesic/ Cold fever/Cough/ decongestant |
| Indication: | Caffeine+ Paracetamol+ Phenylephrine belongs to the class of medication called ‘cough and cold medications’ primarily used to treat symptoms of the common cold and allergies like sneezing, runny/stuffy nose, fever, headache, body pains, congestion, or watery eyes. |
| Storage: | Store in cool, dry place. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Paracetamol 325mg, Caffeine Anhydrous 32mg and Phenylephrine Hydrochloride 10mg Tablet
Paracetamol 500mg, Caffeine Anhydrous 30mg and Phenylephrine Hydrochloride 10mg Tablet
Paracetamol 500mg, Caffeine Anhydrous 32mg and Phenylephrine Hydrochloride 10mg Tablet
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each Uncoated tablet contains:
Paracetamol IP………………………………325mg
Caffeine Anhydrous IP………………………….30mg
Phenylephrine Hydrochloride IP……………10mg
Excipients ……………………………………………. Q.S.
Colour: Approved Colour used.
THERAPEUTIC INDICATIONS:
Caffeine+ Paracetamol+ Phenylephrine belongs to the class of medication called ‘cough and cold medications’ primarily used to treat symptoms of the common cold and allergies like sneezing, runny/stuffy nose, fever, headache, body pains, congestion, or watery eyes.
CAUTION & SCHEDULE:
Keep out the reach of children
Do not use if you are allergic to paracetamol, phenylephrine, caffeine or to any other ingredients in the product.
Discontinue use if signs of allergic reaction appear (e.g. face, mouth or throat swelling, difficulty in breathing itching, mouth ulceration or skin rash or peeling).
Seek medical advice before using this product if you have liver or kidney disease or insufficiency or prostate disease. Avoid if used antidepressants (monoamine oxidase type) within 2 weeks and take with care if you have a history of peptic ulcer.
The product should not be used during pregnancy or breastfeeding unless recommended by HCP
Do not use if the blister or foil is broken.
Not for children under 12 years.
SCHEDULE: H DRUG: WARNING: Not to be sold without prescription of Registered Medical Practitioner.
WARNING & PRECAUSTIONS: Do not use with other paracetamol products or if suffering from severe heart diseases, hypertension or hypothyroidism. Seek medical advice immediately in case of overdose even if you feel well.
STORAGE & DOSAGE:
Storage: Store in cool, dry place.
Dosage: Take 1 tablet every 4-6 hours. Do not exceed 4 tablets in 24-hour period.