acetaminophen, dextromethorphan hbr, diphenhydramine hcl

FDA Drug Profile — Theraflu Severe Cold Relief Combo Pack

Drug Details

Generic Name
acetaminophen, dextromethorphan hbr, diphenhydramine hcl
Brand Names
Theraflu Severe Cold Relief Combo Pack
Application Number
M012
Sponsor
Haleon US Holdings LLC
NDC Codes
2
Dosage Forms
KIT
Routes
N/A
Active Ingredients
N/A

Indications and Usage

Uses temporarily reduces fever and relieves these common cold/flu symptoms: minor aches and pains headache cough due to minor throat and bronchial irritation sore throat runny nose sneezing controls the impulse to cough to help your child get to sleep Uses temporarily reduces fever and relieves these common cold/flu symptoms: minor aches & pains headache cough due to minor throat and bronchial irritation sore throat controls the impulse to cough to help your child get to sleep

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: 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, 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. with any other product containing diphenhydramine, even one used on skin Ask a doctor before use if the child has liver disease glaucoma cough that occurs with too much phlegm (mucus) a breathing problem such as chronic bronchitis persistent or chronic cough such as occurs with asthma or if cough is accompanied by excessive phlegm (mucus). Ask a doctor or pharmacist before use if the child is taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product do not use more than directed marked drowsiness may occur sedatives and tranquilizers may increase the drowsiness effect excitability may occur, especially in children Stop use and ask a doctor if pain or cough gets worse or lasts more than 5 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present 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. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical even if you do not notice any signs or symptoms. 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: 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, 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 the child has liver disease cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with asthma or if cough is accompanied by excessive phlegm (mucus). Ask a doctor or pharmacist before use if the child is taking the blood thinning drug warfarin When using this product do not use more than directed Stop use and ask a doctor if pain or cough gets worse or lasts more than 5 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present 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. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical even if you do not notice any signs or symptoms.