Infants Pain Relief

Description

NDC 68016-160-02. Premier Value® Infants' Pain Relief is a suspension liquid formulation containing acetaminophen as the active ingredient. This product serves as a pain reliever and fever reducer. It is presented in a 2 FL OZ (59 mL) container and is characterized by its cherry flavor. The formulation is free from dyes, alcohol, and aspirin. It is recommended for use only with the enclosed syringe. The product has been independently tested and is backed by a satisfaction guarantee.

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

Healthcare professionals should ensure that the product is shaken well before use. Dosing should be determined using the provided dosing chart, prioritizing weight for accuracy; if weight is not available, age may be used as a secondary measure.

Only the enclosed syringe designed for this product should be utilized for dosing. To prepare the dose, remove the bottle cap and insert the syringe into the hole at the top of the bottle. The bottle should then be turned upside down. Pull back the plunger of the syringe until it is filled slightly above the prescribed level. After this, return the bottle to its original position and gently push the plunger back until the liquid reaches the prescribed level. Carefully remove the syringe from the bottle.

The liquid should be dispensed slowly into the baby's mouth, directed toward the inner cheek. If necessary, the dose may be repeated every 4 hours while symptoms persist, but it is important not to exceed 5 doses within a 24-hour period. After use, the bottle cap should be replaced tightly to ensure child resistance.

For dosing specifics, refer to the following chart:

• For children weighing under 24 lb or under 2 years of age, consult a doctor for the appropriate dose.

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

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or non-prescription, is prohibited. If there is uncertainty regarding the presence of acetaminophen in another medication, consultation with a healthcare professional is advised.

• This product should not be administered to children with a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation.

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.

In the event of a severe sore throat that persists for more than 2 days, or if it is accompanied by fever, headache, rash, nausea, or vomiting, it is imperative to consult a physician promptly. These symptoms may indicate a more serious underlying condition that requires medical evaluation.

General precautions should be taken when administering this product. Healthcare providers should recommend that caregivers consult a physician prior to use if the child is currently taking the anticoagulant warfarin or has a history of liver disease.

In cases of accidental overdose, immediate professional assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222. Timely medical intervention is crucial, even in the absence of noticeable signs or symptoms of overdose.

Caregivers should be instructed to discontinue use and seek medical advice if new symptoms arise, if there is any redness or swelling, if pain worsens or persists beyond 5 days, or if fever intensifies or lasts more than 3 days. These developments may signify a serious condition that necessitates further medical assessment.

Side Effects

Patients using this product should be aware of the potential for serious adverse reactions, particularly concerning liver health. The product contains acetaminophen, and severe liver damage may occur if a child takes more than five doses within a 24-hour period, which is the maximum daily amount. Additionally, the risk of liver damage increases if the product is used concurrently with other medications containing acetaminophen.

It is contraindicated to use this product in conjunction with any other drug containing acetaminophen, whether prescription or non-prescription. Parents or guardians should consult a doctor or pharmacist if there is uncertainty regarding the presence of acetaminophen in other medications. The product should also not be administered to children who are allergic to acetaminophen or any of the inactive ingredients included in the formulation.

Before using this product, it is advisable to consult a healthcare professional if the child is currently taking the blood-thinning medication warfarin or has a history of liver disease.

Patients should discontinue use and seek medical advice if new symptoms arise, if there is any redness or swelling, if pain worsens or persists for more than five days, or if fever intensifies or lasts longer than three days. These symptoms may indicate a serious underlying condition.

An overdose warning is also pertinent; taking more than the recommended dose can lead to serious health complications, including liver damage. In the event of an accidental overdose, immediate professional assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222. Prompt medical attention is crucial, even if no signs or symptoms are immediately apparent.

Drug Interactions

Co-administration of this medication with any other drug containing acetaminophen, whether prescription or non-prescription, is contraindicated due to the risk of acetaminophen overdose, which can lead to severe liver damage.

In pediatric patients, it is advisable to consult a healthcare professional prior to use if the child is concurrently taking warfarin, a blood-thinning agent. This is important to ensure appropriate monitoring and to mitigate the risk of potential interactions that could affect coagulation parameters.

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 doctor for dosing recommendations, while those aged 2 to 3 years weighing between 24 to 35 pounds may receive a dose of 5 mL.

Caution is advised as this product contains acetaminophen, which can lead to severe liver damage if more than 5 doses are administered within a 24-hour period or if used concurrently with other medications containing acetaminophen. It is imperative to avoid using this product with any other acetaminophen-containing drugs, whether prescription or non-prescription. Parents or caregivers should verify the presence of acetaminophen in other medications by consulting a doctor or pharmacist.

This product should not be used in pediatric patients who are allergic to acetaminophen or any inactive ingredients contained in the formulation. Additionally, a healthcare professional should be consulted before use if the child is taking the anticoagulant warfarin or has a history of liver disease.

For dosing, it is recommended to use the child's weight when possible; if weight is not available, age may be used as a guide. Only the enclosed syringe designed for this product should be utilized for dosing; other devices are not appropriate.

Geriatric Use

Elderly patients have not been specifically studied in relation to the use of this product, as it is primarily intended for infants. Consequently, there is no available information regarding dosage adjustments, safety considerations, or clinical findings pertinent to geriatric patients. Healthcare providers should exercise caution when considering the use of this product in elderly patients, as the absence of data may necessitate careful monitoring and evaluation of potential risks and benefits.

Pregnancy

The available prescribing information does not provide specific data regarding the use of this product during pregnancy. Consequently, the safety concerns, dosage modifications, or special precautions for pregnant patients remain undefined. Healthcare professionals should exercise caution when considering this product for women of childbearing potential and weigh the potential risks against the benefits. It is advisable to discuss any concerns with patients and consider alternative therapies if necessary.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk. The effects of this product on a nursing infant are not well studied; therefore, caution is advised.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to using this product, particularly if they have a history of liver disease. The formulation contains acetaminophen, which poses a risk of severe liver damage if the patient exceeds the maximum recommended dosage. Specifically, patients must not take more than five doses within a 24-hour period, as this constitutes the maximum daily amount.

Additionally, patients should avoid concurrent use of other medications that contain acetaminophen, as this can further increase the risk of liver injury. In the event of an overdose, which may occur if the recommended dosage is exceeded, serious health complications, including liver damage, may arise. Immediate medical attention is essential in cases of accidental overdose, and patients or caregivers are advised to contact a Poison Control Center at 1-800-222-1222, even if no symptoms are apparent. Prompt intervention is critical to mitigate potential health risks associated with acetaminophen overdose.

Overdosage

In cases of overdose, the ingestion of more than the recommended dose may lead to significant health complications, particularly liver damage. It is imperative that healthcare professionals remain vigilant regarding the potential severity of such incidents.

Recommended Actions In the event of an accidental overdose, immediate professional assistance should be sought. Healthcare providers are advised to contact a Poison Control Center at 1-800-222-1222 for guidance on management and treatment protocols.

Symptoms and Management Quick medical attention is crucial, even if the patient does not exhibit any immediate signs or symptoms of overdose. Early intervention can be vital in mitigating potential health risks associated with overdose. Healthcare professionals should be prepared to assess the patient’s condition and initiate appropriate management strategies 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

Postmarketing experience has identified rare cases of severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, associated with the use of acetaminophen. Additionally, reports of acute liver failure have been documented, with some cases necessitating liver transplantation, particularly among patients with underlying liver disease or those exceeding the recommended dosage. Instances of allergic reactions, including anaphylaxis, have also been reported. Furthermore, renal impairment has been associated with the use of acetaminophen, especially in patients with pre-existing renal conditions.

Patient Counseling

Healthcare providers should advise patients to keep this medication and all other drugs out of reach of children to prevent accidental ingestion. It is important to inform patients not to use this product in conjunction with any other medications that contain acetaminophen, whether prescription or non-prescription. If patients are uncertain about the presence of acetaminophen in other medications, they should be encouraged to consult a doctor or pharmacist for clarification.

Patients should be cautioned against using this product if their child has a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation. Healthcare providers should instruct patients to discontinue use and seek medical advice if new symptoms arise, if there is any redness or swelling, or if pain worsens or persists beyond five days. Additionally, patients should be advised to stop use and consult a doctor if a fever worsens or lasts more than three days, as these may indicate a serious underlying condition.

It is essential to emphasize the importance of adhering to the recommended dosage and to inform patients about the risks associated with overdose. Healthcare providers should also recommend that patients consult a doctor before using this product if their child is currently taking the blood-thinning medication warfarin or has a history of liver disease.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at controlled room temperature to maintain its integrity and efficacy. Proper handling should be observed to ensure optimal conditions are met throughout the storage period.

Additional Clinical Information

Patients should be advised that the medication is administered orally using only the enclosed syringe specifically designed for this product; other dosing devices should not be used. Dosing may be repeated every 4 hours as needed while symptoms persist, with a maximum of 5 doses within a 24-hour period.

Clinicians should counsel patients to consult a doctor prior to use if the child is taking the anticoagulant warfarin or has liver disease. Additionally, patients should be instructed to discontinue use and seek medical advice if new symptoms arise, if there is redness or swelling, if pain worsens or persists beyond 5 days, or if fever intensifies or lasts more than 3 days.

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.

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