Infants Pain Relief

Description

Acetaminophen is presented in a suspension liquid form, containing 160 mg of acetaminophen per 5 mL. This formulation serves as a pain reliever and fever reducer. It is free from ibuprofen, alcohol, aspirin, and parabens, ensuring a suitable option for individuals with sensitivities to these substances. The product is flavored with grape and is packaged in a 1 fluid ounce (30 mL) container.

Uses and Indications

This drug is indicated for the reduction of fever and the relief of minor aches and pains associated with various conditions, including the common cold, influenza, headache, sore throat, and toothache.

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

Dosage and Administration

This product is intended for pediatric use only and does not contain complete directions or warnings for adult use. Healthcare professionals should ensure that the dosage is not exceeded, adhering to the overdose warning.

Prior to administration, the product must be shaken well. The appropriate dose can be determined using the provided dosing chart, which recommends using the child's weight for dosing whenever possible; otherwise, age may be used as a guide.

To prepare the dose, the following steps should be followed:

1. Push air out of the syringe and insert the syringe tip into the bottle opening.

2. Flip the bottle upside down and pull the yellow part of the syringe to the first dose line, then push the product back into the bottle.

3. Pull the yellow part of the syringe until it reaches and remains at the correct dose.

The liquid should be dispensed slowly into the child’s mouth, directed toward the inner cheek. Dosing may be repeated every 4 hours as needed while symptoms persist, but should not exceed 5 doses within a 24-hour period.

After use, the cap must be replaced tightly to maintain child resistance. It is imperative to use only the enclosed syringe specifically designed for this product; no other dosing devices should be utilized.

The dosing chart is as follows:

• For children weighing under 24 lb or under 2 years of age, the dose should be determined by consulting a doctor.

• For children weighing between 24-35 lb or aged 2-3 years, the recommended dose is 5 mL.

Dosing may also be adjusted as directed by a healthcare professional.

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 history of allergic reactions to this product or any of its ingredients, as this may lead to severe allergic responses.

• Exceeding the recommended dosage is contraindicated, as it poses a risk of overdose.

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 five doses should be administered within a 24-hour period. Additionally, caution is warranted when this product is used concurrently with other medications containing acetaminophen, as this may further increase the risk of liver injury.

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 any skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare providers should also be vigilant regarding sore throat symptoms. If a child presents with a severe sore throat that persists for more than two days, or if it is accompanied or followed 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 be instructed to seek guidance from a doctor or pharmacist if the child is concurrently taking warfarin or any other blood-thinning medication.

In cases of suspected overdose, immediate medical attention is crucial. Caregivers should be directed to contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help without delay, even if no symptoms are apparent.

Healthcare professionals should advise caregivers to discontinue use and consult a physician if any of the following occur: pain worsens or persists beyond five days, fever intensifies or lasts more than three days, new symptoms develop, or if there is any redness or swelling, as these may indicate a serious underlying condition.

Side Effects

Severe adverse reactions associated with this product include significant liver damage, which may occur if a child exceeds five doses within a 24-hour period or if the product is taken concurrently with other medications containing acetaminophen. Patients should be monitored for signs of liver injury, particularly in those with pre-existing liver disease.

Additionally, there is an allergy alert indicating that acetaminophen may lead to severe skin reactions. Symptoms of such reactions can include skin reddening, blisters, and rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Participants should also be aware of the sore throat warning. If a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, it is essential to consult a healthcare provider promptly.

Patients are advised to stop use and consult a doctor if pain worsens or lasts longer than five days, if fever intensifies or persists beyond three days, if new symptoms arise, or if there is any redness or swelling, as these may indicate a serious condition.

Furthermore, it is recommended to seek medical advice before use if the child has liver disease or is taking the anticoagulant warfarin, as interactions may pose additional risks.

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 necessitate careful monitoring of coagulation parameters to avoid potential adverse effects related to increased bleeding risk. Adjustments to the dosage of either medication may be required based on clinical judgment and patient response.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 2 years of age should consult a healthcare professional for dosing recommendations, while those aged 2 to 3 years and weighing between 24 to 35 pounds may receive a dose of 5 mL. It is crucial to adhere strictly to the recommended dosing guidelines and not exceed the directed amount, as an overdose can occur. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center contacted at 1-800-222-1222, as prompt attention is essential even if no symptoms are apparent.

To ensure accurate dosing, caregivers are advised to refer to the dosing chart and, when possible, use the child's weight for determining the appropriate dose. If weight is not available, age may be used as a guide. It is important to utilize only the enclosed syringe specifically designed for this product and to avoid using any other dosing devices. Additionally, this product should be kept out of reach of children to prevent accidental ingestion.

Geriatric Use

Elderly patients may not receive specific directions or complete warnings for adult use with this product. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is essential to consider the unique physiological changes and potential comorbidities that may affect drug metabolism and response in this population.

Due to the lack of tailored guidance, careful monitoring of elderly patients is recommended to ensure safety and efficacy. Providers should assess the need for dosage adjustments based on individual patient factors, including age, weight, renal function, and overall health status. Regular evaluation and communication with patients regarding any adverse effects or concerns are crucial in managing their treatment effectively.

Pregnancy

The available prescribing information does not provide specific data regarding the use of acetaminophen during pregnancy. Consequently, healthcare professionals should exercise caution when recommending acetaminophen to pregnant patients. There are no documented safety concerns, dosage modifications, or special precautions outlined for its use in this population. Given the lack of detailed information, healthcare providers are encouraged to weigh the potential benefits against any unknown risks when considering acetaminophen for women of childbearing potential. Further research may be necessary to establish a clearer understanding of the implications of acetaminophen use during pregnancy.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and caution is advised when administering this product to nursing mothers due to the potential risk to the infant.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if there is a concurrent liver disease. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the degree of impairment. Careful evaluation is necessary to ensure safe and effective use in this population.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to use, particularly if they have a history of liver disease. It is essential to evaluate liver function and consider potential adjustments in dosage or monitoring requirements based on the severity of the impairment. Close monitoring of liver function tests may be warranted to ensure safety and efficacy in this patient population.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt intervention is essential, as the absence of noticeable signs or symptoms does not preclude the potential for serious health consequences.

Healthcare professionals should be aware that quick medical attention can significantly impact the outcome of an overdose situation. Therefore, it is crucial to act swiftly, regardless of the presence of overt symptoms.

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 compound in these areas.

Postmarketing Experience

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions. Reports indicate that symptoms can include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use immediately and seek medical assistance.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose, emphasizing that prompt medical attention is crucial even if no signs or symptoms are apparent.

Patients should be informed not to use this product in conjunction with any other medications that contain acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, patients are encouraged to consult with a doctor or pharmacist.

It is important to instruct patients not to use this product if their child has a history of allergic reactions to it or any of its ingredients. Additionally, patients should be advised to discontinue use and consult a doctor if pain worsens or persists for more than five days, if fever intensifies or lasts longer than three days, if new symptoms arise, or if there is any redness or swelling, as these may indicate a serious condition.

Patients must be reminded to adhere strictly to the recommended dosage to avoid the risk of overdose. Furthermore, healthcare providers should recommend that patients consult a doctor before using this product if their child has liver disease or is currently taking the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in a configuration that includes a printed bottle wrap. It is essential to ensure that the bottle wrap is intact; do not use the product if the wrap is broken or missing.

For optimal storage, the product should be maintained at a temperature range of 68-77°F (20-25°C). Proper handling and storage conditions are crucial to preserve the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered orally, with a recommended repeat dose every 4 hours as needed, not to exceed 5 doses within a 24-hour period. Clinicians should advise patients to consult a doctor before use if the child has liver disease or is taking the anticoagulant warfarin. Patients should discontinue use and seek medical advice if pain worsens or persists beyond 5 days, if fever worsens or lasts more than 3 days, if new symptoms arise, or if there is any redness or swelling.

Drug Information (PDF)

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

View product document (PDF)