Coldtac Plus Softgels
Generic: ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Basic Information
Manufacturer
OPMX LLC.
Product Type
HUMAN OTC DRUG
Route of Administration
ORAL
FDA Set ID
ff5ce5c6-a03f-2ad3-e053-6394a90a99f6
Purpose
Active ingredients (in each Softgel) Purpose Acetaminophen 325 mg Pain reliever/fever reducer Dextromethorphan HBr 10 mg Cough suppressant Phenylephrine HCl 5 mg Nasal decongestant
Indications & Usage
Uses Temporarily relieves common cold/flu symptoms: Nasal congestion Cough due to minor throat & bronchial irritation Sore throat Headache Minor aches & pains Fever
Warnings
Warnings Liver warning This product contains acetaminophen.
Severe liver damage may occur if you take: more than 4 doses in 24 hrs, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks daily while using this product Allergy alert Acetaminophen may cause severe skin reactions.
Symtoms may include.
Skin reddening blisters Rash If a skin reaction occurs, stop use and seek medical help right away.
Sore throat warning If sore throat is severe, lasts 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.
if you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have Liver disease Heart disease Diabetes High blood pressure Trouble urinating due to enlarged prostate gland Cough that occurs with too much phlegm (mucus) Persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis or emphysema.
Ask a doctor or pharmacist before use if you are: T aking the blood thinning drug warfarin.
When using this product, do not use more than directed.
Stop use and ask a doctor if You get nervouz, dizzy or sleepless.
Symptoms get worse or last more than 5 days (children) or 7 days (adults).
Fever gets worse or lasts more than 3 days.
Redness or swelling is present.
New symtoms occur.
Cough comes back, or occurs with rash or headache that lasts.
These could be signs of a serious condition.
Keep out of reach of children.
If pregnant or breast-feeding, ask a health professional before use.
Overdose warning Taking more than directed can cause serious health problems.
In case of overdose, get medical help or contact a Poison Control Center right away.
Quick medical attention is critical for adults as well for children even if you do not notice any signs or symptoms.
Severe liver damage may occur if you take: more than 4 doses in 24 hrs, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks daily while using this product Allergy alert Acetaminophen may cause severe skin reactions.
Symtoms may include.
Skin reddening blisters Rash If a skin reaction occurs, stop use and seek medical help right away.
Sore throat warning If sore throat is severe, lasts 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.
if you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have Liver disease Heart disease Diabetes High blood pressure Trouble urinating due to enlarged prostate gland Cough that occurs with too much phlegm (mucus) Persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis or emphysema.
Ask a doctor or pharmacist before use if you are: T aking the blood thinning drug warfarin.
When using this product, do not use more than directed.
Stop use and ask a doctor if You get nervouz, dizzy or sleepless.
Symptoms get worse or last more than 5 days (children) or 7 days (adults).
Fever gets worse or lasts more than 3 days.
Redness or swelling is present.
New symtoms occur.
Cough comes back, or occurs with rash or headache that lasts.
These could be signs of a serious condition.
Keep out of reach of children.
If pregnant or breast-feeding, ask a health professional before use.
Overdose warning Taking more than directed can cause serious health problems.
In case of overdose, get medical help or contact a Poison Control Center right away.
Quick medical attention is critical for adults as well for children even if you do not notice any signs or symptoms.