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Pseudoephedrine Hydrochloride USP COUGH SYRUP (Pseudoephedrine Hydrochloride 30mg) Cough Syrup is a clear, light pink syrup with a butterscotch flavour.: (products from Taj Pharmaceuticals Limited) INDIAISRAEL MARKET  (Products from Taj Pharmaceuticals Limited) INDIA

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  PRODUCT LIST FOR ISRAEL MARKET: (products from Taj Pharmaceuticals Limited) INDIAISRAEL MARKET  (Products from Taj Pharmaceuticals Limited) INDIA   ISRAEL MARKET  (Products from Taj Pharmaceuticals Limited) INDIA >> Rexafed Syrup

 

GENERIC NAME: Pseudophendrine Hydrochloride 30mg/5ml Syrup

BRAND NAME: REXAFED Syrup

Active Ingredient(s): Pseudophendrine Hydrochloride 30mg/5ml

 Pseudoephedrine Hydrochloride COUGH SYRUP
(Pseudoephedrine Hydrochloride 30mg)

Rx only

DESCRIPTION

Pseudoephedrine Hydrochloride Cough Syrup is a clear, light pink syrup with a
: >> butterscotch flavor.

Each 5 mL (1 teaspoonful) contains:

Pseudoephedrine Hydrochloride, USP . . . . . 30 mg

Alcohol 0.95% v/v

In a palatable, aromatic vehicle.

Inactive Ingredients: artificial butterscotch flavor, citric acid anhydrous, dehydrated alcohol, FD&C Red No. 40, glycerin, liquid sugar, methylparaben, propylene glycol, purified water and sodium benzoate. It may contain 10% citric acid solution or 10% sodium citrate solutionfor pH adjustment. The pH range is between 3.0 and 6.0.

Pseudoephedrine Hydrochloride, USP
(+)-Pseudoephedrine hydrochloride

: Antihistamine/Nasal Decongestant/Antitussive syrup for oral administration.

CLINICAL PHARMACOLOGY

Pseudoephedrine acts on sympathetic nerve endings and also on smooth muscle, making it useful as a nasal decongestant. The nasal decongestant effect is mediated by the action of pseudoephedrine on α-sympathetic receptors, producing vasoconstriction of the dilated nasal arterioles. Following oral administration, effects are noted within 30 minutes with peak activity occurring at approximately one hour.

INDICATIONS AND USAGE

For relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.

CONTRAINDICATIONS

Hypersensitivity to any of the ingredients. Do not use in the newborn, in premature infants, in nursing mothers, or in patients with severe hypertension or severe coronary artery disease. Do not use dextromethorphan in patients receiving monoamine oxidase (MAOI) inhibitors (see Drug Interactions).

Antihistamines should not be used to treat lower respiratory tract conditions including asthma.

WARNINGS

Especially in infants and small children, antihistamines in overdosage may cause hallucinations, convulsions, and death.

Antihistamines may diminish mental alertness. In the young child, they may produce excitation.

PRECAUTIONS

General

Because of its antihistamine component, Pseudoephedrine Hydrochloride  Cough Syrup should be used with caution in patients with a history of bronchial asthma, narrow angle glaucoma, gastrointestinal obstruction, or urinary bladder neck obstruction. Because of its sympathomimetic component, Pseudoephedrine Hydrochloride Cough Syrup should be used with caution in patients with diabetes, hypertension, heart disease, or thyroid disease.

Information for Patients

Patients should be warned about engaging in activities requiring mental alertness, such as driving a car or operating dangerous machinery.

Drug Interactions

Monoamine oxidase (MAO) inhibitors-Hyperpyrexia, hypotension, and death have been reported coincident with the coadministration of MAO inhibitors and products containing dextromethorphan. In addition, MAO inhibitors prolong and intensify the anticholinergic (drying) effects of antihistamines and may enhance the effect of pseudoephedrine. Concomitant administration of Pseudoephedrine Hydrochloride Cough Syrup and MAO inhibitors should be avoided (see CONTRAINDICATIONS).

Carcinogenesis, Mutagenesis, Impairment of Fertility

Animal studies of Pseudoephedrine Hydrochloride Cough Syrup to assess the carcinogenic and mutagenic potential or the effect on fertility have not been performed.

Pregnancy

Teratogenic Effects

Nursing Mothers

Because of the higher risk of intolerance of antihistamines in small infants generally, and in newborns and prematures in particular, Pseudoephedrine Hydrochloride Cough Syrup is contraindicated in nursing mothers.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 6 months have not been established (see DOSAGE AND ADMINISTRATION).

ADVERSE REACTIONS

The most frequent adverse reactions to Pseudoephedrine Hydrochloride Cough Syrup are: sedation; dryness of mouth, nose and throat; thickening of bronchial secretions; dizziness. Other adverse reactions may include:

Dermatologic: Urticaria, drug rash, photosensitivity, pruritus.

Cardiovascular System: Hypotension, hypertension, cardiac arrhythmias, palpitation.

CNS: Disturbed coordination, tremor, irritability, insomnia, visual disturbances, weakness, nervousness, convulsions, headache, euphoria, and dysphoria.

G.U. System: Urinary frequency, difficult urination.

G.I. System: Epigastric discomfort, anorexia, nausea, vomiting, diarrhea, constipation.

Respiratory System: Tightness of chest and wheezing, shortness of breath.

Hematologic System: Hemolytic anemia, thrombocytopenia, agranulocytosis.

OVERDOSAGE

Signs and Symptoms: Central nervous system effects from over-dosage of brompheniramine may vary from depression to stimulation, especially in children. Anticholinergic effects may be noted. Toxic doses of pseudoephedrine may result in CNS stimulation, tachycardia, hypertension, and cardiac arrhythmias; signs of CNS depression may occasionally be seen.

Toxic Doses: Data suggest that individuals may respond in an unexpected manner to apparently small amounts of a particular drug. The toxic dose of pseudoephedrine should be less than that of ephedrine, which is estimated to be 50 mg/kg.

Treatment :Induce emesis if patient is alert and is seen prior to 6 hours following ingestion. Precautions against aspiration must be taken, especially in infants and small children. Gastric lavage may be carried out, although in some instances tracheostomy may be necessary prior to lavage. CNS stimulants may counter CNS depression. Should CNS hyperactivity or convulsive seizures occur, intravenous short-acting barbiturates may be indicated. Hypertensive responses and/or tachycardia should be treated appropriately. Oxygen, intravenous fluids, and other supportive measures should be employed as indicated.

DOSAGE AND ADMINISTRATION

Adults and pediatric patients 12 years of age and over: 2 teaspoonfuls every 4 hours. Children 6 to under 12 years: 1 teaspoonful every 4 hours. Children 2 to under 6 years of age: teaspoonful every 4 hours. Infants 6 months to under 2 years of age: Dosage to be established by a physician.

Do not exceed 6 doses during a 24-hour period.

HOW SUPPLIED

Pseudoephedrine Hydrochloride Cough Syrup is a clear, light pink-colored, butterscotch-flavored syrup containing in each 5 mL (1 teaspoonful, pseudoephedrine hydrochloride 30 mg, available in the following size:

1 Pint (473 mL)

RECOMMENDED STORAGE

Store at 20 to 25 C (68 to 77 F) [See USP Controlled Room Temperature].

KEEP TIGHTLY CLOSED

Dispense in a tight, light-resistant container as defined in the USP.

Pseudoephedrine Hydrochloride USP COUGH SYRUP (Pseudoephedrine Hydrochloride 30mg) Cough Syrup

**** ALL PRODUCTS ARE ONLY AVAILABLE ON GENERIC NAME.



BENACOLD & REXAFED ARE THE REGISTRED BRANDS OF TAJ GROUP- PHARMA DIVISION

Taj Pharmaceuticals logo  Copyright 2004-2011 Taj Pharmaceuticals Limited. All rights reserved. Legal Notice

The products discussed herein may have different product labeling in different countries. The product information provided in this site is intended only for the residents of India.

                    
**** NOTE.

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Pseudoephedrine Hydrochloride USP COUGH SYRUP (Pseudoephedrine Hydrochloride 30mg) Cough Syrup is a clear, light pink syrup with a butterscotch flavour.p: (from Taj Pharmaceuticals Limited) INDIA

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Pseudoephedrine Hydrochloride USP COUGH SYRUP (Pseudoephedrine Hydrochloride 30mg)

Pseudophendrine Hydrochloride syrup: (from Taj Pharmaceuticals Limited) INDIA

Pseudoephedrine Hydrochloride USP COUGH SYRUP (Pseudoephedrine Hydrochloride 30mg) Cough Syrup is a clear, light pink syrup with a butterscotch flavour.: (from Taj Pharmaceuticals Limited) INDIA

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Pseudophendrine Hydrochloride syrup: (from Taj Pharmaceuticals Limited) INDIA



 

           
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Pseudophendrine Hydrochloride syrup: (from Taj Pharmaceuticals Limited) INDIA

ISRAEL MARKET  (Products from Taj Pharmaceuticals Limited) INDIA ISRAEL MARKET  (Products from Taj Pharmaceuticals Limited) INDIA
ISRAEL MARKET  (Products from Taj Pharmaceuticals Limited) INDIA
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 
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