FDA records indicate that there are no current recalls for this drug.
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Pediacare Single Dose Fever Reducer 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 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.
- 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.
liver disease.
taking the blood thinning drug warfarin.
do not exceed recommended dosage (see overdose warning)
- pain gets worse or lasts for more than 5 days.
- fever gets worse or lasts for more than 3 days.
- new symptoms occur.
- redness or swelling is present.
These could be signs of a serious condition.
Overdose warning. Taking more than the recommended dose (overdose) may cause liver damage. In case of accidental 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.
- 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.
liver disease.
Ask a doctor or pharmacist before use if your child istaking the blood thinning drug warfarin.
Stop use and ask a doctor if:- pain gets worse or lasts for more than 5 days.
- fever gets worse or lasts for more than 3 days.
- new symptoms occur.
- redness or swelling is present.
These could be signs of a serious condition.
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
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.
- 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.
liver disease.
taking the blood thinning drug warfarin.
do not exceed recommended dosage (see overdose warning)
- pain gets worse or lasts for more than 5 days.
- fever gets worse or lasts for more than 3 days.
- new symptoms occur.
- redness or swelling is present.
These could be signs of a serious condition.
Overdose warning. Taking more than the recommended dose (overdose) may cause liver damage. In case of accidental 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.
- 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.
liver disease.
Ask a doctor or pharmacist before use if your child istaking the blood thinning drug warfarin.
Stop use and ask a doctor if:- pain gets worse or lasts for more than 5 days.
- fever gets worse or lasts for more than 3 days.
- new symptoms occur.
- redness or swelling is present.
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
- reduces fever
- relieves minor aches and pains due to:
○ the common cold
○ flu
○ headache
○ sore throat
○ toothache
temporarily
- reduces fever
- relieves minor aches and pains due to:
○ the common cold
○ flu
○ headache
○ sore throat
○ toothache
History
There is currently no drug history available for this drug.
Other Information
There are no additional details available for this product.
Sources
Pediacare Single Dose Fever Reducer Manufacturers
-
Medtech Products Inc.
Pediacare Single Dose Fever Reducer | Medtech Products Inc.
• This product does not contain directions or complete warnings for adult use.
• Each packet provides 1 dose for a child who is 48 to 59 pounds or 6 to 8 years of age. If possible, use weight to determine dose; otherwise use age.
To use:
• Fold back at the dotted line to reveal the tear strip.
• Tear across (not up & down) at the exposed tear slit
• Remove and discard strip
• Squeeze medicine into child’s mouth.
• If needed, repeat dose every 4 hours while symptoms last.
• Do not give more than 5 times in 24 hours (see overdose warning).
• Do not give more than 5 days unless directed by a doctor.
• This product does not contain directions or complete warnings for adult use.
• Each packet provides 1 dose for a child who is 36 to 47 pounds or 4 to 5 years of age. If possible, use weight to determine dose; otherwise use age.
To use:
• Fold back at the dotted line to reveal the tear strip.
• Tear across (not up & down) at the exposed tear slit
• Remove and discard strip
• Squeeze medicine into child’s mouth.
• If needed, repeat dose every 4 hours while symptoms last.
• Do not give more than 5 times in 24 hours (see overdose warning).
• Do not give more than 5 days unless directed by a doctor.
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