Childrens Pain Relief

Description

NDC 68016-178-04. Premier Value® Children's 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 alcohol-free, aspirin-free, and ibuprofen-free, making it suitable for pediatric use. The formulation is presented in a bubble gum flavor and is packaged in a 4 FL OZ (118 mL) container. The product has been independently tested, and satisfaction is guaranteed.

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

Shake the product well before use. Healthcare professionals should refer to the dosage chart below to determine the appropriate dose. When possible, dosing should be based on the patient's weight; if weight is not available, age may be used as a guide.

Only the enclosed dosing cup designed for use with this product should be utilized for measuring doses. Other dosing devices are not recommended.

For patients weighing under 24 lb or under 2 years of age, it is advised to consult a doctor before administration.

Dosage Chart:

• For patients weighing 24-35 lb or aged 2-3 years: Administer 1 teaspoon (5 mL).

• For patients weighing 36-47 lb or aged 4-5 years: Administer 1½ teaspoons (7.5 mL).

• For patients weighing 48-59 lb or aged 6-8 years: Administer 2 teaspoons (10 mL).

• For patients weighing 60-71 lb or aged 9-10 years: Administer 2½ teaspoons (12.5 mL).

• For patients weighing 72-95 lb or aged 11 years: Administer 3 teaspoons (15 mL).

If necessary, the dose may be repeated every 4 hours while symptoms persist. However, do not exceed 5 doses in a 24-hour period. Additionally, do not administer the product for more than 5 consecutive days unless directed by a physician.

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 a 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.

Additionally, it is imperative to adhere to the recommended dosage, as exceeding this may lead to overdose, which poses significant health risks.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the child exceeds the maximum daily dosage of 5 doses within a 24-hour period or if it is taken 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 healthcare professional promptly.

Healthcare providers should inquire about the child’s medical history before recommending this product, particularly if the child has a history of liver disease. Additionally, it is advisable to consult a doctor or pharmacist if the child is currently taking the anticoagulant medication warfarin, as interactions may occur.

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

Patients should discontinue use and contact a healthcare provider 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 longer than 3 days. These symptoms may indicate a serious underlying condition that requires medical 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 is exceeded, specifically if more than five doses are taken within a 24-hour period or if the product is used concurrently with other medications containing acetaminophen. Patients with liver disease should consult a healthcare professional before using this product. Additionally, caution is advised for patients taking blood-thinning medications such as warfarin, and they should seek guidance from a doctor or pharmacist prior to use.

In the event of a sore throat, if symptoms are severe, persist for more than two days, or are accompanied by fever, headache, rash, nausea, or vomiting, patients are advised to consult a doctor promptly.

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

It is critical to adhere to the recommended dosage to avoid overdose, which can lead to serious health issues, including liver damage. In cases of accidental overdose, immediate professional assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted, as prompt medical attention is essential even in the absence of noticeable signs or symptoms.

Drug Interactions

Co-administration of this medication with any other drug containing acetaminophen, whether prescription or non-prescription, is contraindicated. Patients should be advised to consult a healthcare professional if there is uncertainty regarding the presence of acetaminophen in other medications.

Additionally, caution is advised when this medication is used in conjunction with warfarin, a blood-thinning agent. It is recommended that patients seek guidance from a healthcare provider prior to use if they are currently taking warfarin, to ensure appropriate monitoring and management of potential interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Childrens 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 before use. For those aged 2 to 3 years weighing between 24-35 pounds, the recommended dose is 1 teaspoon (5 mL). Children aged 4 to 5 years and weighing 36-47 pounds may receive 1½ teaspoons (7.5 mL). For children aged 6 to 8 years weighing 48-59 pounds, the dose is 2 teaspoons (10 mL), while those aged 9 to 10 years and weighing 60-71 pounds may take 2½ teaspoons (12.5 mL). Finally, children aged 11 years and weighing 72-95 pounds can be administered 3 teaspoons (15 mL).

Caution is advised as this product contains acetaminophen, which can lead to severe liver damage if more than 5 doses are taken within a 24-hour period, including doses from other acetaminophen-containing medications. Parents or guardians should seek medical advice before use if the child has liver disease or is concurrently taking the anticoagulant warfarin.

Geriatric Use

Elderly patients may not have specific information regarding the use of this product, as the prescribing information does not provide guidance tailored to this population. Additionally, the absence of directions or complete warnings for adult use suggests that caution should be exercised when considering this product for geriatric patients.

Healthcare providers are advised to carefully evaluate the potential risks and benefits when prescribing this product to elderly patients, taking into account the lack of established safety and efficacy data in this demographic. Monitoring for adverse effects and adjusting dosages as necessary may be prudent in the management of treatment in geriatric patients.

Pregnancy

Pregnant patients should be advised against the use of this product if they have a known allergy to acetaminophen or any of the inactive ingredients contained within. 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, and to consult with a physician prior to administration.

Additionally, caution is warranted if the pregnant patient is concurrently taking anticoagulant medications such as warfarin, as interactions may pose risks to both maternal and fetal health.

Healthcare professionals should also inform pregnant patients about the serious health risks associated with overdose, which can lead to significant complications, including liver damage. In the event of an accidental overdose, immediate medical attention is crucial, and patients should be instructed to contact a Poison Control Center (1-800-222-1222) without delay, even if no symptoms are present.

Lactation

Nursing 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 be closely monitored when using this product, which contains acetaminophen. It is critical to note that severe liver damage may occur if the maximum daily amount of more than 5 doses is exceeded within a 24-hour period. Additionally, patients should be advised that taking acetaminophen in conjunction with other medications containing acetaminophen can also lead to severe liver damage.

Before administering this product, it is essential to consult a healthcare professional if the patient has a history of liver disease. The risk of serious health complications, including liver damage, increases significantly with the ingestion of doses exceeding the recommended amount. In the event of an accidental overdose, immediate professional assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted. Prompt medical attention is crucial, even if the patient does not exhibit any signs or symptoms of overdose.

Overdosage

In the event of an overdose, defined as the ingestion of more than the recommended dose, serious health complications may arise, including potential liver damage. It is imperative that healthcare professionals remain vigilant regarding the risks associated with overdosing.

In cases of accidental overdose, immediate action is essential. Healthcare providers should advise patients or caregivers to seek professional assistance without delay. Contacting a Poison Control Center at 1-800-222-1222 is strongly recommended to ensure appropriate guidance and intervention.

It is crucial to emphasize that prompt medical attention is necessary, even in the absence of noticeable signs or symptoms of overdose. Early intervention can significantly mitigate the risk of severe health consequences.

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

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this and all medications out of the reach of children to prevent accidental ingestion. It is important to inform patients not to use this product in conjunction with any other medication containing 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. They should be instructed 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, if a fever intensifies or lasts more than three days, patients should be advised to stop use and consult a doctor, as these may indicate a serious underlying condition.

While using this product, it is crucial for patients to adhere strictly to the recommended dosage to avoid the risk of overdose. Healthcare providers should also recommend that patients consult a doctor prior to use if their child has liver disease. Furthermore, patients taking the anticoagulant warfarin should be advised to seek guidance from a doctor or pharmacist before using this product.

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 the product remains within the recommended temperature range throughout its storage period.

Additional Clinical Information

The medication is administered orally, with a recommended dosing frequency of every 4 hours as needed, not to exceed 5 doses within a 24-hour period. Continuous use should not extend beyond 5 days unless directed by a healthcare professional.

Clinicians should counsel patients to consult a doctor prior to use if the child has liver disease or is concurrently taking the anticoagulant warfarin. Patients are advised to discontinue use and seek medical attention 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, as these may indicate a serious condition.

Drug Information (PDF)

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

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