Acetaminophen Sustained Release Tablets USP 1000mg Technical Specification:
| Product Name: | Acetaminophen Sustained Release Tablets USP 1000mg |
| Brand Name: | Generic |
| Strength: | 500mg, 650mg, 1000mg |
| Dosage Form: | Tablet (Uncoated) |
| Route of Administration: | Via Oral Route |
| Packing: | 8s, 10s, 15s, 100s, 150s |
| 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 650mg
Acetaminophen Sustained Release Tablets USP 1000mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Acetaminophen Sustained Release Tablets USP 1000mg
Each Uncoated Tablet Contains:
Acetaminophen USP…………………………..300 mg
(As Immediate Release)
Acetaminophen USP……………………………700 mg
(As Sustained Release)
Excipients………………………………………Q.S.
Colour: Carmoisine
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 AREGISTERED 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.