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Oxycodone Hydrochloride and Acetaminophen Tablet USP (7.5mg + 375mg) Oxycodone Hydrochloride 7.5mg and Acetaminophen 375mg Tablet USP Oxycodone Hydrochloride 7.5mg and Acetaminophen 375mg Tablet USP Oxycodone Hydrochloride 7.5mg and Acetaminophen 375mg Tablet USP Oxycodone Hydrochloride 7.5mg and Acetaminophen 375mg Tablet USP

GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Oxycodone Hydrochloride and Acetaminophen Tablet USP (7.5 mg + 375 mg)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a. Oxycodone Hydrochloride and Acetaminophen Tablet USP (7.5 mg + 375 mg)
Each film -coated Extended-Release tablet contain:
Oxycodone Hydrochloride USP………7.5mg
Acetaminophen USP…………………325mg
Excipients…………………………q.s.
Color: Titanium Dioxide USP

THERAPEUTIC INDICATIONS:

This combination medication is used to help relieve moderate to severe pain. It contains an opioid pain reliever (oxycodone) and a non-opioid pain reliever (acetaminophen). Oxycodone works in the brain to change how your body feels and responds to pain. Acetaminophen can also reduce a fever.

CAUTION & WARNING:

CAUTION:
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Take whole tablet with water.
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
WARNING:
To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage:
Store at controlled room temperature of 20°C to 25°C (68° to 77°F); excursions permitted to 15°C to 30°C (59 to 86°F) [see USP Controlled room Temperature].
Protect from light & moisture.
Keep in a cool & dry place.
Dosage:
As directed by the Physician

Oxycodone Hydrochloride and Acetaminophen Tablet USP (7.5mg + 375mg) Technical Specification:

Product Name:Oxycodone Hydrochloride and Acetaminophen Tablet USP (7.5mg + 375mg)
Brand Name:OXYCONTEX II Vance
Strength:(7.5mg + 375mg)
Dosage Form:Extended-Release Tablets (film-coated)
Route of Administration:Via Oral Route
Packing:10s, 20s, 30s, 50s, 150s
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Opiate (narcotic) Analgesics, Antipyretics
Indication: This combination of medications is used to help relieve moderate to severe pain. It contains an opioid pain reliever (oxycodone) and a non-opioid pain reliever (acetaminophen). Oxycodone works in the brain to change how your body feels and responds to pain. Acetaminophen can also reduce a fever.
Storage:Store at a controlled room temperature of 20°C to 25°C (68° to 77°F); excursions permitted to 15°C to 30°C (59 to 86°F) [see USP Controlled Room Temperature].

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Oxycodone Hydrochloride and Acetaminophen Tablet USP (7.5 mg + 375 mg)

 QUALITATIVE AND QUANTITATIVE COMPOSITION:

  •  Oxycodone Hydrochloride and Acetaminophen Tablet USP (7.5 mg + 375 mg)
    Each film-coated Extended-Release tablet contains:
    Oxycodone Hydrochloride USP………7.5mg
    Acetaminophen USP…………………325mg
    Excipients…………………………q.s.
    Color: Titanium Dioxide USP 

THERAPEUTIC INDICATIONS:

This combination of medications is used to help relieve moderate to severe pain. It contains an opioid pain reliever (oxycodone) and a non-opioid pain reliever (acetaminophen). Oxycodone works in the brain to change how your body feels and responds to pain. Acetaminophen can also reduce a fever.

CAUTION & WARNING:

CAUTION:
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Take the whole tablet with water.
Read the enclosed leaflet before use.
Keep the medicine out of reach of children.

WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage:
Store at a controlled room temperature of 20°C to 25°C (68° to 77°F); excursions permitted to 15°C to 30°C (59 to 86°F) [see USP Controlled Room Temperature].
Protect from light & moisture.
Keep in a cool & dry place.

Dosage:
As directed by the Physician.