FDA records indicate that there are no current recalls for this drug.
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Flu Relief Childrens Recall
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Questions & Answers
Side Effects & Adverse Reactions
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 contaning 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- to make a child sleepy
- 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.
- if your child is allergic to acetaminophen or any of the inactive ingredients in this product.
- liver disease
- glaucoma
- thyroid disease
- diabetes
- heart disease
- high blood pressure
- a breathing problem such as chronic bronchitis
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with asthma
- sedatives or tranquilizers
- the blood thinning drug warfarin
- do not exceed recommended dose (see overdose warning )
- excitability may occur, especially in children
- marked drowsiness may occur
- sedatives and tranquilizers may increase drowsiness
- new symptoms occur
- redness or swelling is present
- pain, nasal congestion or cough gets worse or last more than 5 days
- fever gets worse or last more than 3 days
- nervousness, dizziness or sleeplessness occurs
- 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: Taking more than the recommended dose (overdose) could cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs or symptoms.
Do not use- to make a child sleepy
- 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.
- if your child is allergic to acetaminophen or any of the inactive ingredients in this product.
- liver disease
- glaucoma
- thyroid disease
- diabetes
- heart disease
- high blood pressure
- a breathing problem such as chronic bronchitis
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with asthma
- sedatives or tranquilizers
- the blood thinning drug warfarin
- new symptoms occur
- redness or swelling is present
- pain, nasal congestion or cough gets worse or last more than 5 days
- fever gets worse or last more than 3 days
- nervousness, dizziness or sleeplessness occurs
- cough comes back or occurs with rash or headache that lasts,
These could be signs of a serious condition.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
- temporarily relieves the following cold/flu symptoms:
- minor aches and pains
- sore throat
- cough
- sneezing and runny nose
- headache
- stuffy nose
- temporarily reduces fever
History
There is currently no drug history available for this drug.
Other Information
There are no additional details available for this product.
Sources
Flu Relief Childrens Manufacturers
-
Top Care (Topco Associates Llc)
Flu Relief Childrens | Top Care (topco Associates Llc)
this product does not contain directions or complete warnings for adult use. mL =milliliter shake well before using measure only with dosing cup provided do not use with any other dosing device keep dosing cup with product do not give more than 5 times in 24 hours if needed, repeat dose every 4 hours while symptoms last find the right dose on chart below. If possible, use weight to dose: otherwise, use age. Weight (lb) Age (yr) Dose ( mL) 48-95 6-11 10 mL 36-47 4-5 do not use unless directed by a doctor under 36 under 4 do not use
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