Daytime Cold and Flu Relief
Generic: DAYTIME COLD AND FLU RELIEF
Basic Information
Manufacturer
TopCo Associates, LLC
Product Type
HUMAN OTC DRUG
Route of Administration
ORAL
FDA Set ID
d592fbb8-d4bf-444e-982e-edf6fe97dce4
Purpose
Purpose Pain reliever/fever reducer Cough suppressant Nasal decongestant
Indications & Usage
Use(s) 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 every day while using this product Allergy Alert: Acetaminophen may cause severe skin reactions.
Symptoms 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, persists for more than 2 days, occurs with or is 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 drugs.
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 • liver disease • heart disease • thyroid disease • diabetes • high blood pressure • trouble urinating due to an enlarged prostate gland • cough that occurs with too much phlegm (mucus) • persistent or chronic cough as occurs with smoking, asthma, or emphysema Ask a doctor or pharmacist before use if taking the blood thinning drug warfarin.
When using this product do not use more than directed Stop use and ask a doctor if • you get nervous, 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 symptoms occur • cough comes back, or occurs with rash or headache that lasts.
These could be signs of a serious condition.
If pregnant or breastfeeding, ask a health professional before use.
Keep out of reach of children Taking more than directed can cause serious health problems.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Quick medical attention is critical for adults as well as 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 every day while using this product Allergy Alert: Acetaminophen may cause severe skin reactions.
Symptoms 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, persists for more than 2 days, occurs with or is 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 drugs.
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 • liver disease • heart disease • thyroid disease • diabetes • high blood pressure • trouble urinating due to an enlarged prostate gland • cough that occurs with too much phlegm (mucus) • persistent or chronic cough as occurs with smoking, asthma, or emphysema Ask a doctor or pharmacist before use if taking the blood thinning drug warfarin.
When using this product do not use more than directed Stop use and ask a doctor if • you get nervous, 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 symptoms occur • cough comes back, or occurs with rash or headache that lasts.
These could be signs of a serious condition.
If pregnant or breastfeeding, ask a health professional before use.
Keep out of reach of children Taking more than directed can cause serious health problems.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Quick medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.