FDA records indicate that there are no current recalls for this drug.
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Cough And Sore Throat 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
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- more than 5 doses in 24 hours, which is the maximum daily amount
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- with other drugs containing 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.
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- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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- 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.
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- if your child has ever had an allergic reaction to this product or any of its ingredients
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- liver disease
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- persistent or chronic cough such as occurs with asthma
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- cough that occurs with too much phlegm (mucus)
taking the blood thinning drug warfarin
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- pain or cough gets worse or lasts more than 5 days
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- fever gets worse or lasts more than 3 days
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- redness or swelling is present
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- new symptoms occur
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- cough comes back or occurs with rash or headache that lasts
These could be signs of a serious condition.
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical even if you do not notice any signs or symptoms.
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- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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- 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 has ever had an allergic reaction to this product or any of its ingredients
- •
- liver disease
- •
- persistent or chronic cough such as occurs with asthma
- •
- cough that occurs with too much phlegm (mucus)
taking the blood thinning drug warfarin
Stop use and ask a doctor if- •
- pain or cough gets worse or lasts more than 5 days
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- fever gets worse or lasts more than 3 days
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- redness or swelling is present
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- new symptoms occur
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- 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
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- temporarily relieves the following cold/flu symptoms:
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- minor aches and pains
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- headache
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- sore throat
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- cough
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- 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
Cough And Sore Throat Childrens Manufacturers
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Cvs Pharmacy
Cough And Sore Throat Childrens | Cvs Pharmacy
• this product does not contain directions or complete warnings for adult use • do not give more than directed (see Liver warning) • shake well before using • find right dose on chart below. If possible, use weight to dose; otherwise, use age. • use only enclosed dosing cup designed for use with this product. Do not use any other dosing device. • if needed, repeat dose every 4 hours while symptoms last • do not give more than 5 times in 24 hours • do not give for more than 5 days unless directed by a doctorWeight (lb)
Age (yr)
Dose (tsp or mL)
under 36 lbs
under 4 years
do not use
36-47 lbs
4 - 5 years
1 tsp or 5 mL
48-95 lbs
6 - 11 years
2 tsp or 10 mL
Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
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Hyvee Inc
Cough And Sore Throat Childrens | Hyvee Inc
• this product does not contain directions or complete warnings for adult use • do not give more than directed (see Overdose warning) • shake well before using • may be given every 4 hours, while symptoms persist. Do not give more than 5 doses in 24 hours unless directed by a doctor. • use enclosed dosing cup only. Keep for use with this product only. Do not use any other dosing device.Age
Dose
children under 4 years of age
do not use
children 4 to under 6 years of age
1 teaspoonful (5 mL)
children 6 to under 12 years of age
2 teaspoonfuls (10 mL)
teaspoonful = tsp
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