VICKS COUGH LOZENGES WITH HONEY

LOZENGE FOR ORAL ADMINISTRATION.

COUGH SUPPRESSANT FOR THE RELIEF OF DRY, IRRITANT COUGH ASSOCIATED WITH COMMON COLD AND INFLUENZA.

ADULTS AND CHILDREN OVER 12;

2 LOZENGES DISSOLVED IN THE MOUTH CONSECUTIVELY. REPEAT EVERY 6 HOURS AS NEEDED. NO MORE THAN 8 LOZENGES PER DAY.

KNOWN HYPERSENSITIVITY TO DEXTROMETHORPHAN OR TO ANY INGREDIENT OF THE LOZENGE.

PATIENTS SUFFERING FROM SEVERE LIVER DISEASE.

PATIENTS RECEIVING MONOAMINE OXIDASE INHIBITOR THERAPY OR WHO HAVE TAKEN A MONOAMINE OXIDASE INHIBITOR WITHIN THE LAST TWO WEEKS

PATIENTS WITH A PRODUCTIVE COUGH

PATIENTS SUFFERING FROM ASTHMA, LIVER DISEASE OR IMPAIRED RESPIRATORY FUNCTION SHOULD CONSULT THEIR DOCTOR BEFORE TAKING THIS PRODUCT.

DO NOT ADMINISTER TO CHILDREN UNDER 12 YEARS.

IF SYMPTOMS PERSIST CONSULT YOUR DOCTOR..

DO NOT EXCEED THE STATED DOSE.

KEEP OUT OF REACH OF CHILDREN.

SEE SECTION 4.3 REGARDING MAOI THERAPY.

THERE IS NO LITERATURE EVIDENCE OF HAZARD DUE TO DEXTROMETHORPHAN BUT USE IS NOT RECOMMENDED DURING THE FIRST TRIMESTER AND DURING BREAST FEEDING.

PATIENTS SUFFERING FROM THE UNDESIRABLE EFFECTS OF DIZZINESS, EXCITATION OR MENTAL CONFUSION (SEE SECTION 4.8) SHOULD NOT DRIVE OR OPERATE MACHINERY.

REACTIONS ARE UNCOMMON, BUT MAY INCLUDE DIZZINESS, EXCITATION, MENTAL CONFUSION AND GASTROINTESTINAL DISTURBANCES.

SYMPTOMS

MILD TO MODERATE OVERDOSAGE MAY CAUSE DIZZINESS, EXCITATION, MENTAL CONFUSION AND GASTROINTESTINAL DISTURBANCES. VERY HIGH DOSES MAY PRODUCE RESPIRATORY DEPRESSION.

TREATMENT OF OVERDOSE

GASTRIC LAVAGE AND GENERAL SUPPORTIVE MEASURES.

DEXTROMETHORPHAN IS A NON-OPIOID DEXTRO-ISOMER OF MORPHINE. THE DRUG'S COUGH SUPPRESSANT ACTION IS MEDIATED BY A CENTRAL ACTION ON THE COUGH CENTRE IN THE MEDULLA OBLONGATA OF THE BRAIN, RAISING THE THRESHOLD FOR COUGHING.

DEXTROMETHORPHAN BASE IS WELL ABSORBED FROM THE GASTROINTESTINAL TRACT, BUT THERE IS EXTENSIVE FIRST-PASS METABOLISM. METABOLISM OCCURS IN THE LIVER BY DEMETHYLATION, AND THE DRUG IS EXCRETED IN THE URINE AS UNCHANGED DEXTROMETHORPHAN AND DEMETHYLATED METABOLITES INCLUDING DEXTRORPHAN WHICH HAS SOME COUGH SUPPRESSANT ACTIVITY. THERE IS NO FAECAL ELIMINATION. URINARY EXCRETION IS NEGLIGIBLE. VARIATION IN CAPACITY TO METABOLISE DEXTROMETHORPHAN EXISTS BETWEEN INDIVIDUALS AND THE CLINICAL IMPLICATIONS OF THIS ARE NOT FULLY UNDERSTOOD.

N/A.

SUCROSE

GLUCOSE SYRUP

LACTIC ACID

CITRIC ACID MONOHYDRATE

POTASSIUM HYDROXIDE

LEVOMENTHOL

HONEY

HONEY FLAVOUR L-134515

EUCALYPTUS OIL

WATER

NONE KNOWN.

SHELF LIFE (UNOPENED): 3 YEARS

SHELF LIFE (AFTER OPENING

BLISTER PACK): AS FOR UNOPENED PRODUCT

STORE BELOW 25^oC

POLYPROPYLENE BLISTER FOIL, WHITE IN COLOUR, WITH BACKING FOIL (PAPER/ALUMINIUM/POLYPROPYLENE BASED ADHESIVE) CONTAINING 12 LOZENGES.

OR

POLYVINYLCHLORIDE/POLYVINYLIDENE CHLORIDE BLISTER FOIL, WHITE IN COLOUR, WITH BACKING FOIL (PAPER/ALUMINIUM/POLYVINYLIDENE BASED ADHESIVE) CONTAINING 12 LOZENGES.

NONE.

PROCTER & GAMBLE (HEALTH & BEAUTY CARE) LIMITED

THE HEIGHTS

BROOKLANDS

WEYBRIDGE

SURREY

KT13 0XP

UK

PL 0129/0129

N/A

JUNE 2007