Acetaminophen Extended-Release Tablets USP 650mg
| Product Name: | Acetaminophen Extended-Release Tablets USP 650mg |
| Brand Name: | Generic |
| Strength: | 500mg, 650mg, 1000mg |
| Dosage Form: | Tablet (Uncoated) |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 30s, 100s, 1000s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Documents: | COA, MOA, Stability Studies, GMP, DMF, COPP, FSD and CTD Dossier |
| Therapeutic use: | Analgesics, Antipyretics |
| Indication: | To treat mild to moderate pain. |
| Storage: | Store at 20° to 25°C. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Acetaminophen Tablets USP 500mg
Acetaminophen Extended-Release Tablets USP 650m
Acetaminophen Sustained Release Tablets USP 1000mg
QUALITATIVE AND QUANTITATIVE COMPOSITION
A. Acetaminophen Extended-Release Tablets USP 650mg
Each Uncoated Tablet Contains:
Acetaminophen USP…………………650 mg
Excipients………………………….Q.S
THERAPEUTIC INDICATIONS
It is used to relieve mild or moderate pain, such as headaches, toothache or sprains and reduce fevers caused by illnesses such as colds and flu.
CAUTION & WARNING:
CAUTION
Keep medicine out of reach of children.
Taking more than daily dose of Acetaminophen may cause serious liver damage or allergic reactions such as swelling of face, mouth and throat; difficulty in breathing, itching and rashes.
WARNING:
TO BE SOLD BY RETAIL ON THE PRESCRIPTION OF A registered medical practitioner ONLY.
STORAGE & DOSAGE:
STORAGE: Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F)
DOSAGE: As directed by the Physician.