GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Paracetamol, Pseudoephedrine & Diphenhydramine Tablets (500mg+30mg+25mg)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a. Paracetamol, Pseudoephedrine & Diphenhydramine Tablets (500mg+30mg+25mg)
Each film-coated tablet contain:
Paracetamol……………………500mg
Pseudoephedrine HCL…………500mg
Diphenhydramine HCL…………30mg
Excipients…………………………q.s.
Color: Titanium Dioxide USP

THERAPEUTIC INDICATIONS:

Acetaminophen, diphenhydramine, and pseudoephedrine is a combination medicine used to treat headache, fever, body aches, runny or stuffy nose, sneezing, itching, watery eyes, and sinus congestion caused by allergies, the common cold, or the flu.

CAUTION & WARNING:

CAUTION:
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
DO NOT STOP OR SKIP MEDICINE WITHOUT PHYSICIAN’S ADVICE.
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.
DO NOT CONSUME MORE THAM THE PRESCRIBED QUANTITY.

STORAGE & DOSAGE:

Storage:
Store at Temperature not exceeding 30ºC.
Protect from light & moisture.
Keep in a cool & dry place.
Dosage:
As directed by the Physician

Paracetamol, Pseudoephedrine & Diphenhydramine Tablets (500mg+30mg+25mg) Technical Specification:

Product Name:Paracetamol 500 mg, Pseudoephedrine 30 mg & Diphenhydramine 25 mg Tablets
Brand Name:REXAFED-FLU
Strength:(500mg+30mg+25mg)
Dosage Form:Film-Coated Tablet
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:Analgesic, Antipyretic, Nasal Decongestants, Antihistamines, Antiemetic Agents
Indication: Acetaminophen, diphenhydramine, and pseudoephedrine is a combination of medications used to treat headache, fever, body aches, runny or stuffy nose, sneezing, itching, watery eyes, and sinus congestion caused by allergies, the common cold, or flu.
Storage:Protected from Light and Moisture at temperatures not exceeding 30ºC. Do not Frieze.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Paracetamol, Pseudoephedrine & Diphenhydramine Tablets (500mg+30mg+25mg)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  •  Paracetamol, Pseudoephedrine & Diphenhydramine Tablets (500mg+30mg+25mg)
    Each film-coated tablet contains: 
    Paracetamol……………………500mg
    Pseudoephedrine HCL…………500mg
    Diphenhydramine HCL…………30mg
    Excipients…………………………q.s. 
    Color: Titanium Dioxide USP

THERAPEUTIC INDICATIONS:

Acetaminophen, diphenhydramine, and pseudoephedrine is a combination of medications used to treat headache, fever, body aches, runny or stuffy nose, sneezing, itching, watery eyes, and sinus congestion caused by allergies, the common cold, or flu.

CAUTION & WARNING:

CAUTION:
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
DO NOT STOP OR SKIP MEDICINE WITHOUT A PHYSICIAN’S ADVICE.

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.

DO NOT CONSUME MORE THAN THE PRESCRIBED QUANTITY.

STORAGE & DOSAGE:

Storage:
Store at a temperature not exceeding 30ºC.
Protect from light & moisture.
Keep in a cool & dry place. 

Dosage:
As directed by the Physician.