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OTC - Ameflu - Cough and cold preparations - Ameflu Night Time

COMPOSITION:

Acetaminophen 500 mg

Pseudoephedrine HCl 30 mg

Dextromethorphan HBr 15 mg

Chlorpheniramine maleate 2 mg

Per each film coated caplet.


INDICATIONS:

For temparary relief of nasal congestion, runny nose, sneezing, water and itchy eyes, couhg, sore throat, headaches, body aches, and fever due to the common cold, hay fever, or other upper respiratory allergies.


ADMINISTRATION AND DOSAGE:

Adults and children from 12 years and older: Take 1 caplet every 4-6 hours, not to exceed 8 caplets in 24 hours.

Children (6-11 years): Take 1/2 caplet every 4-6 hours, not to exceed 4 caplets in 24 hours.
Not for use in children under 6 years of age.


CONTRAINDICATIONS:

Hypersensitivity to any of ingredients of Ameflu Night Time caplet.

Patient who are receiving MAOIs (see interaction section) in 14 days

Severe hepatic / renal failure.

G6DP insufficiency

Pregnancy or breast-feeding women.

Patients with acute asthma, prostatomegaly, glaucoma,

Bladder neck obstruction.

Gastricl ulcer, pyloro-duodenal obstruction.


WARNINGS AND PRECAUTIONS:

Do not take for pain for more than 7 days or for fever for more than 3 days unless directed by a doctor.

May cause drowsiness. Alcohol, sedatives and tranquilizers may increase the drowsiness effect.

Avoid alcoholic beverages while taking this product.

Do not take this product if you are taking sedatives and tranquilizers without previously consulting your doctor.

If pain or fever persists or get worse, if new symptoms occur, or if redness or swelling is present, consult a doctor because these could be signs of a serious condition.

If sore throat is severe, persists for more than 2 days, is accompanied by fever, headache, rash, nausea or vomiting, consult a doctor promptly.

A persistent cough is a sign of serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash or persistent headache, consult a doctor.

Do not take this product for persistent or chronic cough such as occurs with smoking, asthma or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.

If nervousness, dizziness, or sleeplessness occurs, discontinue use and consult a doctor.

Do not take this product unless directed by a doctor:
+ If you have a breathing problem such as emphysema or chronic bronchitis.
+ If you have glaucoma.
+ Difficulty in urination due to enlargement of prostate gland.
+ Heart disease, high blood pressure, thyroid disease or diabetes.

Do not use with other products containing acetaminophen.

Effects on ability to drive and operate machine:

Use caution when driving vehicle or operating machinery.

Use in pregnancy and breast-feeding: ask a doctor before use.


SIDE EFFECTS:

May cause drowsiness.

There are rare cases of allergy such as: skin rash, erythema or urticaria. Other side effects are restlessness, headache, dizziness, tiredness, dry mouth, nausea, urinary, retention,diplopia.

May cause excitability, especially in children.


INTERACTIONS:

Do not take this product if you are now taking a prescription of monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains a MAOI, ask a doctor or pharmacist before taking this product.


PRESENTATION:

Box of 1 blister x 10 coated caplets.

Box of 10 blisters x 10 coated caplets