FDA records indicate that there are no current recalls for this drug.
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Childrens Multi-symptom Cold Plus Dye-free Recall
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Questions & Answers
Side Effects & Adverse Reactions
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.
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
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.
- to make a child sleepy
- 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.
- with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- if your child is allergic to acetaminophen or any of the inactive ingredients in this product
- a breathing problem such as chronic bronchitis
- persistent or chronic cough such as occurs with asthma
- cough that occurs with too much phlegm (mucus)
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- glaucoma
- liver disease
- 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
- fever gets worse or lasts for more than 3 days
- redness or swelling is present
- pain, nasal congestion or cough gets worse or lasts for more than 5 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.
Overdose warning: Taking more than the recommended dose (overdose) may 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.
- to make a child sleepy
- 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.
- with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- if your child is allergic to acetaminophen or any of the inactive ingredients in this product
- a breathing problem such as chronic bronchitis
- persistent or chronic cough such as occurs with asthma
- cough that occurs with too much phlegm (mucus)
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- glaucoma
- liver disease
- sedatives or tranquilizers
- the blood thinning drug warfarin
- new symptoms occur
- fever gets worse or lasts for more than 3 days
- redness or swelling is present
- pain, nasal congestion or cough gets worse or lasts for more than 5 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
- cough
- headache
- sore throat
- sneezing and runny nose
- 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
Childrens Multi-symptom Cold Plus Dye-free Manufacturers
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Quality Choice (Chain Drug Marketing Association)
Childrens Multi-symptom Cold Plus Dye-free | Quality Choice (chain Drug Marketing Association)
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 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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