OTC - Other products - New Baby Flu
COMPOSITION: Each 0.8 ml contains:
Acetaminophen 80 mg
Phenylephrine HCl 2.4 mg
Excipients: Propylene glycol, citric acid, sodium benzoate, glycerine, sorbitol 70%, polyethylene glycol 400, tutti frutti flavor, ponceu 4R, quinoline yellow, sucralose, purified water.
Temporarily relieves the common cold symptoms: Minor aches and pains, headache, sore throat, stuffy nose and fever.
ADMINISTRATION AND DOSAGE:
Only used for oral, not drop in the nose.
Shake well before using. To use enclosed dropper (0.8 ml), fill to prescribed level.
- Children from 6 to 11 years of age: take 2 droppers, every 4 hours.
- Children from 4 to 5 years of age: take 1 dropper, every 4 hours.
- Children from 2 to 3 years: take ½ dropper, every 4 hours or directed by a doctor.
Do not take more than 5 times in 24 hours.
- The patients who are hypersensitive to any ingredients of this product.
- Patients who are receiving MAOIs (see Drug interaction section).
- Concomitant use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- Patients who have coronary disease and severe hypertension.
- G6DP insufficiency.
- Patients with severe hepatic failure.
- Narrow-angle glaucoma.
- Children under 2 years.
WARNINGS AND PRECAUTIONS:
Children under 4 years of age.
Do not exceed recommended dosage.
Ask doctor before use it if children have
- Liver disease, heart disease, high blood pressure, thyroid disease, diabetes.
- Persistent or chronic cough such as occurs with asthma.
- Cough that occurs with too much phlegm (mucus).
Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin.
Stop use and ask a doctor if:
- Nervousness, dizziness or sleeplessness occur.
- Pain or nasal congestion gets worse or lasts more than 5 days.
- Fever gets worse or lasts more than 3 days.
- Redness or swelling is present.
- New symptoms occur.
- Cough comes back or occurs with rash or headache that lasts.
These could be signs of a serious condition.
There are rare cases of allergy such as: rash, hives, itching. Other side effects are difficulty breathing, tightness in the chest, slow or irregular heartbeat, hallucinations, blurred vision, hypertension, seizures, stomach pain, tremor, weakness, dizziness, excitability, headache, nausea, nervousness or anxiety, trouble sleeping, chills, pale skin.
In case of an unexpected reaction, consult your physician.
- Do not take this product if your child is 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 child’s prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
- Phenytoin, barbiturate, carbamazepin, isoniazid may increase the hepatotoxicity of Acetaminophen.
- Concomitant use of phenylephrine with other sympathomimetic amines can increase the risk of cardiovascular side effects.
- Phenylephrine may reduce the efficacy of beta-blocking drugs and antihypertensive drugs (including debrisoquine, guanethidine, reserpine, methyldopa). The risk of hypertension and other cardiovascular side effects may be increased.
- Tricyclic antidepressants (e.g. amitriptyline, imipramine): May increase the risk of cardiovascular side effects with phenylephrine.
- Concomitant use of phenylephrine with ergot alkaloids (ergotamine and methylsergide): Increase the risk of ergotism.
- Concomitant use of phenylephrine with digoxin: Increase the risk of irregular heartbeat or heart attack.
- Concomitant use of phenylephrine with atropine will block the reflex bradycardia that phenylephrine causes.
OVERDOSE AND TREATMENT:
Symptoms: Nausea, vomiting and abdominal pain (normally settle within 24 hours of ingestion). After 24 hours symptoms may include right subcostal pain and tenderness, usually indicates development of hepatic necrosis. Liver damage is greatest 3-4 days after ingestion and may lead to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema and death.
Treatment: Treatment is based on plasma concentration. Acetylcysteine protects the liver if administered within 24 hours after ingestion (most effective if given within 8 hours). Dose: 140 mg/kg orally (loading) followed by 70 mg/kg every 4 hours for 17 doses. Activated charcoal or gastric lavage may be treated to decrease absorption of Acetaminophen.
Symptoms: Hypertension, headache, convulsions, cerebral haemorrhage, palpitation, slow heart rate.
Treatment: Should provide symptomatic and supportive care.
Bottle of 15 ml per box .
STORAGE: Store at temperature from 15oC to 30oC.
SHELF-LIFE: 24 months from manufacturing date. Do not use after expiry date.