Fever ‘n Flu Night Time Sachets

Description

PHARMACEUTICAL FORM:
Sachets.

PROPERTIES:
FEVER’N FLU night time sachets contain a clinically proven analgesic-antipyretic, a decongestant and an antihistaminic agent. Paracetamol produces analgesia by elevation of the pain threshold and antipyresis through action on the hypothalamic heat-regulating center. Paracetamol is equal to aspirin in analgesic and anti-pyretic effectiveness and it is unlikely to produce many of the side effects associated with aspirin and aspirin containing products. Pseudoephedrine HCl is a sympathomimetic amine which provides temporary relief of nasal congestion. Diphenhydramine HCl is an antihistamine which helps provide temporary relief of runny nose and sneezing.

PHARMACOKINTETICS:
– Paracetamol is readily absorbed from gastrointestinal tract with peak plasma concentration occurring about 10 to 60 minutes after oral doses.
– Paracetamol is distributed into most body tissues, it crosses the placenta and is present in breast milk.
– Paracetamol plasma protein binding is negligible at usual therapeutic concentrations,The elimination half-life varies about 1 to 3 hours.
– Paracetamol is metobolised predominantly in the liver and excreted in the urine mainly as glucuronide and sulfate conjugates.
– Pseudoephedrine is readily absorbed from the gastrointestinal tract.
– It is excreted largely unchanged in the urine with small amounts of its hepatic metabolites .
– It has a half life of about 5 to 8 hours.
– Small amounts are distributed in breast milk.
– Diphenhydramine hydrochloride is well absorbed from gastrointestinal tract.
– Peak plasma concentrations are achieved about 1 to 4 hours after oral doses.
– Diphenhydramine is widely distributed throughout the body including CNS and crosses the placenta and has been detected in breast milk.
– Diphenhydramine is highly bound to plasma proteins and is excreted mainly in urine.
– The elimination half life has been reported to range from 2.4 to 9.3 hours.

INDICATIONS:
– Effective temporary relief of body aches, headaches, fever, sore throat and nasal congestion and runny nose, sneezing due to cold or flu.

DOSAGE:
Adults and children 12 years and over:
Dissolve two packets in a cup of hot water. Sip while hot. Sweeten to taste if desired. May be repeated every 6 hours, not to exceed 8 packets in 24 hours.
Maximum daily intake of sucrose is 42 gm.
Maximum daily dose of paracetamol is 4 gm.

SIDE EFFECTS:
Fever & Flu night time sachets are safe and well tolerated. As with other products containing antihistaminics, mild sedation might occur.

CONTRAINDICATIONS:
Hypersensitivity to any ingredient of the product, high blood pressure, or hyperthyroidism.

DRUG INTERACTIONS:
Do not take this product if you are presently taking a prescription drug for high blood pressure or you are now taking a prescription MAOI or for 2 weeks after stopping MAOI drug.

PREGNANCY & LACTATION:
If you are pregnant or nursing a baby, seek the advice of a health professional before using this product.
WARNINGS & PRECAUTIONS:
Not to be used for children less than 12 years old. If a rare sensitivity reaction occurs, the drug should be stopped. Although pseudoephedrine is virtually without pressor effect in normotensive patients, it should be used with caution in hypertensives. The recommended dosage is not to be exceeded because at higher doses, nervousness, dizziness or sleeplessness may occur. The product is not to be taken for more than 7 days or for fever for more than 3 days unless directed by a doctor. If symptoms do not improve, or are accompanied by fever, a doctor is consulted. If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, and nausea or vomiting, a doctor is promptly consulted. The product is not to be taken in diabetes unless directed by a doctor. Caution is taken when driving a motor vehicle or operating machinery. Other products containing paracetamol are not to be used. Do not take this product unless directed by the physician especially if you have breathing problems such as: emphysema or chronic bronchitis. May cause marked drowsiness: Alcohol, sedatives and tranquilizers may increase the drowsiness effect.

PACKING:
A box containing 6 sachets.

STORAGE:
Keep at a temperature not exceeding 30oC, in dry place.
Keep out of reach of children.

INSTRUCTIONS TO PATIENTS:
– Do not exceed recommended dosage.