Pain and Fever

Description

Children's Pain & Fever Chewables contain 160 mg of acetaminophen as the active ingredient. This formulation is presented in the form of chewable tablets, specifically designed for children aged 2 to 11 years. The product is available in a grape flavor and is packaged with a total of 24 chewable tablets. It is free from aspirin and ibuprofen. Administration requires that the tablets be chewed or crushed completely before swallowing. A tamper evident warning is included, stating that the product should not be used if the package is opened or if the blister unit is torn, broken, or shows any signs of tampering.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with headache, sore throat, flu, toothache, and the common cold. Additionally, it is indicated for the temporary reduction of fever.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

This product is intended for use in pediatric patients, and healthcare professionals should refer to the dosage chart to determine the appropriate dose based on the patient's weight or age. It is essential to adhere to the following guidelines for administration:

• The recommended dosing intervals are every 4 hours as needed while symptoms persist. However, the total number of doses should not exceed 5 doses within a 24-hour period.

• Treatment should not extend beyond 5 consecutive days unless directed by a physician.

• Tablets must be chewed or crushed completely before swallowing; they should not be swallowed whole.

Dosage Chart:

• For patients weighing under 24 lb or under 2 years of age, consultation with a doctor is advised.

• For patients weighing 24-35 lb (2-3 years): administer 1 chewable tablet.

• For patients weighing 36-47 lb (4-5 years): administer 1 ½ chewable tablets.

• For patients weighing 48-59 lb (6-8 years): administer 2 chewable tablets.

• For patients weighing 60-71 lb (9-10 years): administer 2 ½ chewable tablets.

• For patients weighing 72-95 lb (11 years): administer 3 chewable tablets.

Dosage should be adjusted as necessary based on clinical judgment and individual patient response.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, due to the risk of acetaminophen overdose. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

• In patients with a known allergy to acetaminophen or any of the inactive ingredients in this product, as this may lead to severe allergic reactions.

• Exceeding the recommended dosage is contraindicated, as it may increase the risk of adverse effects.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the maximum daily dosage is exceeded. Specifically, healthcare professionals should advise caregivers that no more than 5 doses should be administered within a 24-hour period. Additionally, caution is warranted if the product is used concurrently with other medications containing acetaminophen.

Severe skin reactions have been associated with acetaminophen use. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare providers should be vigilant regarding sore throat symptoms. If a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a physician is recommended.

General precautions should be taken when administering this product. It is advisable to consult a physician prior to use if the child has a history of liver disease. Furthermore, caregivers should seek guidance from a doctor or pharmacist if the child is concurrently taking the anticoagulant warfarin.

In cases of overdose, immediate medical attention is crucial. Caregivers should be instructed to contact a Poison Control Center or seek emergency medical help without delay, regardless of the presence of symptoms.

Healthcare professionals should advise caregivers to discontinue use and consult a physician if any of the following occur: pain worsens or persists beyond 5 days, fever intensifies or lasts more than 3 days, new symptoms arise, or if redness or swelling is observed. These signs may indicate a serious underlying condition that requires further evaluation.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions.

Severe liver damage may occur if the maximum daily amount of acetaminophen, which is more than 5 doses in 24 hours, is exceeded, or if it is taken concurrently with other medications containing acetaminophen. Patients should also be alerted to the risk of severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

Additionally, if a patient experiences a sore throat that is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, they should consult a healthcare professional promptly.

This product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Patients should verify the presence of acetaminophen in other medications with a doctor or pharmacist if uncertain. It is also contraindicated in patients with a known allergy to acetaminophen or any of the inactive ingredients in the formulation.

Before using this product, patients with liver disease should consult a doctor. Furthermore, those taking the blood-thinning medication warfarin should seek advice from a healthcare professional or pharmacist prior to use.

While using this product, it is crucial not to exceed the recommended dosage. Patients should discontinue use and consult a doctor if pain worsens or lasts more than 5 days, if fever worsens or lasts more than 3 days, if new symptoms arise, or if redness or swelling is observed, as these may indicate a serious condition.

In cases of overdose, immediate medical attention is essential. Patients should contact a Poison Control Center or seek medical help right away, as prompt intervention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

Drug Interactions

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking warfarin, a blood-thinning agent. The combination may increase the risk of bleeding due to potential pharmacodynamic interactions.

Additionally, this medication should not be used in conjunction with any other products containing acetaminophen, whether prescription or over-the-counter. The risk of acetaminophen overdose and associated hepatotoxicity may be heightened. If there is uncertainty regarding the presence of acetaminophen in other medications, it is advisable to seek guidance from a healthcare provider.

Packaging & NDC

Below are the non-prescription pack sizes of Pain and Fever (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 2 to 11 years may receive this medication according to the following dosing guidelines. It is essential to adhere to the recommended dosages and not exceed the maximum frequency of administration. Dosing should be based on weight when possible; otherwise, age may be used. The medication can be repeated every 4 hours while symptoms persist, but should not be administered more than 5 times within a 24-hour period. Additionally, treatment should not exceed 5 days unless directed by a healthcare professional.

The dosing chart is as follows:

• For patients under 24 lb: Consult a doctor for children under 2 years and for 2-year-olds.

• For patients weighing 24-35 lb (ages 2-3 years): 1 tablet.

• For patients weighing 36-47 lb (ages 4-5 years): 1 ½ tablets.

• For patients weighing 48-59 lb (ages 6-8 years): 2 tablets.

• For patients weighing 60-71 lb (ages 9-10 years): 2 ½ tablets.

• For patients weighing 72-95 lb (age 11 years): 3 tablets.

Healthcare professionals should advise parents or guardians to consult a doctor before use if the child has liver disease or is taking the anticoagulant warfarin. It is crucial to keep this medication out of reach of children. In the event of an overdose, immediate medical assistance or contact with a Poison Control Center is necessary.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

Pregnant patients should be advised against using this product if they have a known allergy to acetaminophen or any of the inactive ingredients. It is essential for healthcare providers to assess the potential risks associated with the use of this product in pregnant patients, particularly those with pre-existing liver disease, as this may exacerbate underlying conditions. Additionally, caution is warranted if the patient is concurrently taking anticoagulants such as warfarin, as interactions may pose risks to both maternal and fetal health.

Healthcare professionals should emphasize the importance of keeping this product out of reach of children to prevent accidental ingestion. In the event of an overdose, immediate medical assistance should be sought, and contacting a Poison Control Center is recommended. Prompt medical attention is critical for both adults and children, regardless of the presence of symptoms, to mitigate potential adverse effects.

Lactation

There are no specific warnings or recommendations regarding the use of this product in lactating mothers. Additionally, there are no statements concerning the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical to adhere to the maximum daily dosage of 5 doses within a 24-hour period to mitigate the risk of hepatotoxicity.

Before administration, it is advised that a healthcare professional be consulted if the patient has a history of liver disease. This precaution is essential to ensure the safe use of the product and to evaluate the need for any dosage adjustments or additional monitoring based on the patient's liver function status.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, it is essential to monitor the patient closely and provide appropriate interventions as necessary.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

Acetaminophen has been associated with severe skin reactions, as reported in postmarketing surveillance. Symptoms of these reactions may include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

Additionally, cases of overdose have been reported, emphasizing the importance of obtaining medical help or contacting a Poison Control Center without delay. Prompt medical attention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose, emphasizing that prompt medical attention is critical for both adults and children, even if no signs or symptoms are apparent.

Patients should be instructed not to exceed the recommended dosage, as doing so may lead to adverse effects. They should also be informed to discontinue use and consult a doctor if pain worsens or persists for more than 5 days, or if fever intensifies or lasts longer than 3 days.

Additionally, patients should be made aware that they need to stop using the medication and seek medical advice if new symptoms arise or if there is any redness or swelling, as these may indicate a serious condition.

For pediatric patients, healthcare providers should recommend consulting a doctor before use if the child has liver disease. Furthermore, it is important to advise patients to speak with a doctor or pharmacist before administering the medication if the child is currently taking the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in tamper-evident packaging. It should not be used if the outer package is opened or if the blister is torn or broken.

Storage conditions require the product to be maintained at a temperature of 25°C (77°F), with permissible excursions between 15°C and 30°C (59°F to 86°F). It is essential to avoid high humidity during storage. For reference, the expiration date and lot number can be found on the end flap of the packaging.

Additional Clinical Information

Patients should be advised that the medication is administered orally, with tablets needing to be chewed or crushed completely before swallowing; whole tablets should not be swallowed. Dosing can be repeated every 4 hours as long as symptoms persist, but should not exceed 5 doses within a 24-hour period. Additionally, the medication should not be used for more than 5 consecutive days unless directed by a healthcare professional.

Clinicians should counsel patients to keep the medication out of reach of children. In the event of an overdose, it is crucial to seek medical assistance or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even if no symptoms are apparent.

Drug Information (PDF)

This file contains official product information for Pain and Fever, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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