GENERIC NAME OF THE MEDICINAL PRODUCT:

Tapentadol Hydrochloride+Carisoprodol Tablet 225mg
Tapentadol Hydrochloride+Carisoprodol Tablet 450mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Tapentadol Hydrochloride+Carisoprodol Tablet 225mg
Each Film coated tablet contains:
Tapentadol Hydrochloride...…………...100mg
Carisoprodol USP………………………125mg
Excipients……………………………q.s.
Colours: Yellow Iron Oxide

b) Tapentadol Hydrochloride+Carisoprodol Tablet 450mg
Each Film coated tablet contains:
Tapentadol Hydrochloride...…………...100mg
Carisoprodol USP………………………350mg
Excipients……………………………q.s.
Colours: Quinoline Yellow

THERAPEUTIC INDICATIONS:

Tapentadol tablets are used to treat moderate to severe acute pain (pain that begins suddenly, has a specific cause, and is expected to go away when the cause of the pain is healed). Tapentadol extended-release tablets are used to treat severe neuropathic pain (pain caused by nerve damage) in people who have diabetes.

CAUTION & WARNING:

CAUTION:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
SCHEDULE “H” Prescription Drug -Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber.

STORAGE & DOSAGE:

Storage: Protect form moisture at a temperature not exceeding 30˚C.Do not freeze. Keep the container tightly closed in order to protect from moisture.
Dosage: As directed by the Physician.

Tapentadol Hydrochloride+Carisoprodol Tablet 450mg Technical Specification:

Product Name:
 Tapentadol Hydrochloride+Carisoprodol Tablet
Brand Name: Generics
Strength: (225mg), (450mg)
Dosage Form: Tablets (Film Coated)
Route of Administration: Via oral Route
Packing: 30s, 90s, 100s
Pack Insert/Leaflet: PIL (Patient Information Leaflet)
Regulatory Documents: COA, MOA, Stability Studies, GMP
Therapeutic use: Analgesics, Opiate (Narcotic), Pain reliever
Indication: Trospium chloride tablets are a muscarinic antagonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. The recommended dose is 20 mg twice daily.
Storage: Protect form moisture at a temperature not exceeding 30˚C.Do not freeze. Keep the container tightly closed in order to protect from moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Tapentadol Hydrochloride+Carisoprodol Tablet 225mg
  • Tapentadol Hydrochloride+Carisoprodol Tablet 450mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • a) Tapentadol Hydrochloride+Carisoprodol Tablet 225mg
    Each Film coated tablet contains:
    Tapentadol Hydrochloride………………100mg
    Carisoprodol USP………………………125mg
    Excipients……………………………q.s.
    Colours: Yellow Iron Oxide
  • b) Tapentadol Hydrochloride+Carisoprodol Tablet 450mg
    Each Film coated tablet contains:
    Tapentadol Hydrochloride………………100mg
    Carisoprodol USP………………………350mg
    Excipients……………………………q.s.
    Colours: Quinoline Yellow

THERAPEUTIC INDICATIONS:

  • Tapentadol tablets are used to treat moderate to severe acute pain (pain that begins suddenly, has a specific cause, and is expected to go away when the cause of the pain is healed). Tapentadol extended-release tablets are used to treat severe neuropathic pain (pain caused by nerve damage) in people who have diabetes.

CAUTION & WARNING:

  • CAUTION:
    Read enclosed leaflet before use.
    Keep medicine out of reach of children.
    SWALLOW WHOLE DO NOT CHEW OR CRUSH
  • SCHEDULE “H” Prescription Drug -Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber.

STORAGE & DOSAGE:

  • Storage:  Protect form moisture at a temperature not exceeding 30˚C.Do not freeze. Keep the container tightly closed in order to protect from moisture.
  • Dosage:  As directed by the Physician.