FDA records indicate that there are no current recalls for this drug.
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Questions & Answers
Side Effects & Adverse Reactions
- Liver warning: This product contains acetaminophen. Severe liver damage may occur if the child takes:
- more than 5 doses in 24 hours, which is maximum daily amount
- with other drugs containing acetaminophen
- Sore throat warning: if sore throat is severe, persists for more than 2 days, or 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). Ask a doctor or pharmacist before using with other drugs if you are not sure.
- 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 dose (see overdose warning)
- pain gets worse or lasts more than 5 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- 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 right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
- with any other drug containing acetaminophen (prescription or non prescription). Ask a doctor or pharmacist before using with other drugs if you are not sure.
- 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 dose (see overdose warning)
- pain gets worse or lasts more than 5 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- 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 right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
liver disease
taking the blood thinning drug warfarin
do not exceed recommended dose (see overdose warning)
- pain gets worse or lasts more than 5 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- 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 right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
taking the blood thinning drug warfarin
do not exceed recommended dose (see overdose warning)
- pain gets worse or lasts more than 5 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- 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 right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
- pain gets worse or lasts more than 5 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- 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 right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
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
- sore throat
- flu
- toothache
- headache
History
There is currently no drug history available for this drug.
Other Information
There are no additional details available for this product.
Sources
Infants Pain Relief Dye-free Manufacturers
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Winco Foods, Llc
Infants Pain Relief Dye-free | Winco Foods, Llc
this product does not contain directions or complete warnings for adult dosedo not give more than directed (see overdose warning)
shake well before use
use only enclosed dosing syringe find right dose on chart below remove cap and insert syringe, invert the bottle and draw the liquid to the prescripbed level. dispense liquid slowly into childs mouth towards inner cheek repeat dose every 4 hours if needed do not give more than 5 times in 24 hours replace the cap tightly to maintain child resistance return dispenser to the box after thorough cleaning Weight (lb) Age (yr) Dose (mL)* under 24 under 2 years ask a doctor 24-35 lbs 2-3 years 5 mL* or as directed by a doctor
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