CHILDRENS COLD COUGH and SORE THROAT MIXED BERRY
Generic: ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL
Basic Information
Manufacturer
AptaPharma Inc.
Product Type
HUMAN OTC DRUG
Route of Administration
ORAL
FDA Set ID
5962a73e-72e4-493b-94a7-43bc6cf9c82f
Purpose
Purpose Acetaminophen ……....……....
Pain reliever/fever reducer Dextromethorphan HBr …....Cough suppressant Guaifenesin ………….....…..….
Expectorant Phenylephrine HCI …...……….Nasal decongestant
Pain reliever/fever reducer Dextromethorphan HBr …....Cough suppressant Guaifenesin ………….....…..….
Expectorant Phenylephrine HCI …...……….Nasal decongestant
Indications & Usage
Uses • temporarily relieves these common cold and flu symptoms: • nasal congestion • stuffy nose • minor aches and pains • sore throat • headache • fever • cough due to minor throat and bronchial irritation • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tube
Warnings
Warnings Liver warning: This product contains acetaminophen.
Severe liver damage may occur if your child takes • more than 5 doses in 24 hours, which is the maximum daily amount • with other drugs containing acetaminophen Allergy alert: Acetaminophen may cause severe skin reactions.
Symptoms may include • skinreddening • blisters • rash.
If skin reaction occurs, stop use and seek medical help right away.
Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly.
Do not 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.
• in a child who is taking a prescription 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 giving this product.
Ask a doctor before use if your child has • Iiver disease • heart disease • high blood pressure • thyroid disease • diabetes • a breathing problem such as chronic bronchitis • 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.
When using this product • do not use more than directed (see Overdose warning) Stop use and ask a doctor if • redness or swelling is present • nervousness, dizziness or sleeplessness occur • new symptoms occur • pain, nasal congestion or cough gets worse or lasts more than 5 days • fever gets worse or lasts more than 3 days • cough comes back, or occurs with rash or headache that lasts.
These could be signs of a serious condition.
Severe liver damage may occur if your child takes • more than 5 doses in 24 hours, which is the maximum daily amount • with other drugs containing acetaminophen Allergy alert: Acetaminophen may cause severe skin reactions.
Symptoms may include • skinreddening • blisters • rash.
If skin reaction occurs, stop use and seek medical help right away.
Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly.
Do not 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.
• in a child who is taking a prescription 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 giving this product.
Ask a doctor before use if your child has • Iiver disease • heart disease • high blood pressure • thyroid disease • diabetes • a breathing problem such as chronic bronchitis • 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.
When using this product • do not use more than directed (see Overdose warning) Stop use and ask a doctor if • redness or swelling is present • nervousness, dizziness or sleeplessness occur • new symptoms occur • pain, nasal congestion or cough gets worse or lasts more than 5 days • fever gets worse or lasts more than 3 days • cough comes back, or occurs with rash or headache that lasts.
These could be signs of a serious condition.