FDA records indicate that there are no current recalls for this drug.
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Leader Pain Reliever Infants 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 nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
liver disease
taking the blood thinning drug warfarin
- pain 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
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.
with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Ask a doctor before use if your child hasliver 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 more than 5 days
- fever gets worse or lasts 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
History
There is currently no drug history available for this drug.
Other Information
There are no additional details available for this product.
Sources
Leader Pain Reliever Infants Manufacturers
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Cardinal Health
Leader Pain Reliever Infants | Cardinal Health
do not give more than directed (see Liver warning) shake well before using find right dose on chart. If possible, use weight to dose; otherwise use age. use only enclosed dropper designed for use with this product. Do not use any other dosing device. fill to dose level dispense liquid slowly into child’s mouth, toward inner cheek 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 doctor replace dropper tightly to maintain child resistance this product does not contain directions or complete warnings for adult use Dosing Chart Weight(lb) Age(yr) Dose (mL) under 24 under 2 years ask a doctor 24-35 2–3 years 1.6 mL (0.8 + 0.8 mL)Attention: use only enclosed dropper specifically designed for use with this product. Do not use any other dosing device.
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