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Levocetirizine Hydrochloride and Pseudoephedrine Hydrochloride SR Tablets (5mg+120mg)  Levocetirizine Hydrochloride and Pseudoephedrine Hydrochloride SR Tablets (5mg+120mg)  Levocetirizine Hydrochloride and Pseudoephedrine Hydrochloride SR Tablets (5mg+120mg)  Levocetirizine Hydrochloride and Pseudoephedrine Hydrochloride SR Tablets (5mg+120mg)  Levocetirizine Hydrochloride and Pseudoephedrine Hydrochloride SR Tablets (5mg+120mg)  Levocetirizine Hydrochloride and Pseudoephedrine Hydrochloride SR Tablets (5mg+120mg)

GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Levocetirizine Hydrochloride and Pseudoephedrine Hydrochloride SR Tablets (5mg+120mg)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Levocetirizine Hydrochloride and Pseudoephedrine Hydrochloride SR Tablets (5mg+120mg)
Each Uncoated Sustained-Release tablet contain:
Levocetirizine Hydrochloride USP………….5mg
(As Immediate Release)
Pseudoephedrine Hydrochloride USP………120mg
(As Sustained-Release)
Excipients……………………………………q.s.
Color: Ferric Oxide Red USP-NF

THERAPEUTIC INDICATIONS:

LEVOCETIRIZINE+PSEUDOEPHEDRINE is a respiratory medication, primarily used to treat symptoms of the common cold, flu, and allergies such as sneezing, runny nose, nasal and sinus congestion, stuffy nose, or watery eyes.
LEVOCETIRIZINE+PSEUDOEPHEDRINE consists of two medicines: Levocetirizine (antihistamine) and Pseudoephedrine (decongestant). Levocetirizine belongs to the class of antihistamines or anti-allergic that works by blocking the action of histamine, a substance responsible for causing allergic reactions.

CAUTION & WARNING:

CAUTION:
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Take whole tablet with water.
Read enclosed leaflet before use.
WARNING:
To be sold by retail on the prescription of a Registered Medical Practitioner only.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
DO NOT STOP OR SKIP MEDICINE WITHOUT PHYSICIAN’S ADVICE.
DO NOT CONSUME MORE THAM THE PRESCRIBED QUANTITY.
Alert: Stop taking REXAFED OD SR Tablet
and consult your doctor immediately if:
1-nervousness, sleepiness, or dizziness
2. Gestures/thoughts of harming yourself

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

Levocetirizine Hydrochloride and Pseudoephedrine Hydrochloride SR Tablets (5mg+120mg) Technical Specification:

Product Name:Levocetirizine Hydrochloride 5mg & Pseudoephedrine Hydrochloride 120mg SR Tablets
Brand Name:REXICOLD
Strength:(5mg+120mg)
Dosage Form:Sustained-Release Tablets (Uncoated)
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:Antihistamines, Anti-Allergic, Decongestant
Indication: LEVOCETIRIZINE+PSEUDOEPHEDRINE is a respiratory medication, primarily used to treat symptoms of the common cold, flu, and allergies such as sneezing, runny nose, nasal and sinus congestion, stuffy nose, or watery eyes.
LEVOCETIRIZINE+PSEUDOEPHEDRINE consists of two medicines: Levocetirizine (antihistamine) and Pseudoephedrine (decongestant). Levocetirizine belongs to the class of antihistamines or anti-allergic that works by blocking the action of histamine, a substance responsible for causing allergic reactions.
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:

  • Levocetirizine Hydrochloride and Pseudoephedrine Hydrochloride SR Tablets (5mg+120mg)

 QUALITATIVE AND QUANTITATIVE COMPOSITION:

  •  Levocetirizine Hydrochloride and Pseudoephedrine Hydrochloride SR Tablets (5mg+120mg)
    Each Uncoated Sustained-Release tablet contains:
    Levocetirizine Hydrochloride USP………….5mg
    (As Immediate Release)
    Pseudoephedrine Hydrochloride USP………120mg
    (As Sustained-Release)
    Excipients……………………………………q.s.
    Color: Ferric Oxide Red USP-NF 

THERAPEUTIC INDICATIONS:

LEVOCETIRIZINE+PSEUDOEPHEDRINE is a respiratory medication, primarily used to treat symptoms of the common cold, flu, and allergies such as sneezing, runny nose, nasal and sinus congestion, stuffy nose, or watery eyes.
LEVOCETIRIZINE+PSEUDOEPHEDRINE consists of two medicines: Levocetirizine (antihistamine) and Pseudoephedrine (decongestant). Levocetirizine belongs to the class of antihistamines or anti-allergic that works by blocking the action of histamine, a substance responsible for causing allergic reactions.

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. 

DO NOT STOP OR SKIP MEDICINE WITHOUT A PHYSICIAN’S ADVICE.

DO NOT CONSUME MORE THAN THE PRESCRIBED QUANTITY.

Alert:

Stop taking REXAFED OD SR Tablet
and consult your doctor immediately if:
1-nervousness, sleepiness, or dizziness
2-Gestures/thoughts of harming yourself.

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.