Good Sense Childrens Ibuprofen

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the reduction of fever and the relief of minor aches and pains associated with conditions such as the common cold, influenza, sore throat, headaches, and toothaches.

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

Dosage and Administration

Tablets should be chewed or crushed completely before swallowing. This product does not provide directions or complete warnings for adult use. Healthcare professionals should ensure that patients do not exceed the recommended dosage.

Dosing should be determined using the chart provided below, prioritizing weight for dosing whenever possible; if weight is not available, age may be used as a secondary measure. If necessary, doses may be repeated every 6 to 8 hours, but the total daily administration should not exceed four doses.

Dosing Chart:

• For patients weighing less than 24 lb or under 2 years of age: Tablets - consult a doctor.

• For patients weighing 24-35 lb or aged 2-3 years: Tablets - 1.

• For patients weighing 36-47 lb or aged 4-5 years: Tablets - 1 ½.

• For patients weighing 48-59 lb or aged 6-8 years: Tablets - 2.

• For patients weighing 60-71 lb or aged 9-10 years: Tablets - 2 ½.

• For patients weighing 72-95 lb or aged 11 years: Tablets - 3.

It is imperative to adhere strictly to these guidelines to ensure safe and effective use of the product.

Contraindications

Use is contraindicated in patients with a history of allergic reactions to ibuprofen or any other pain reliever or fever reducer. Additionally, administration is contraindicated in the perioperative period surrounding heart surgery due to potential complications.

Warnings and Precautions

Ibuprofen may induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of an allergic response may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. In the event of an allergic reaction, it is imperative to discontinue use immediately and seek medical assistance.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of severe stomach bleeding. The likelihood of such an event is heightened in pediatric patients with a history of stomach ulcers or bleeding disorders, those concurrently using anticoagulants or steroid medications, or those taking other NSAIDs (including aspirin, ibuprofen, naproxen, or similar agents). Additionally, exceeding the recommended dosage or duration of treatment increases this risk.

NSAIDs, excluding aspirin, are associated with an elevated risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced when the medication is used in excess of the recommended dosage or for prolonged periods.

Healthcare professionals should be vigilant for signs of severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, as these symptoms may indicate a serious condition. Consultation with a physician is advised if such symptoms occur. The use of ibuprofen should not exceed two days, nor should it be administered to children under three years of age unless specifically directed by a healthcare provider.

In cases of overdose, immediate medical attention is required. Healthcare providers should instruct caregivers to contact a Poison Control Center (1-800-222-1222) without delay.

Healthcare professionals should advise caregivers to discontinue use and consult a physician if the child exhibits any of the following signs of stomach bleeding: feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Additionally, symptoms suggestive of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, warrant immediate medical evaluation.

If the child does not experience relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, or if redness or swelling occurs in the affected area, medical advice should be sought. Caregivers should also be alert for the emergence of any new symptoms and consult a healthcare professional as necessary.

Side Effects

Patients using ibuprofen may experience a range of adverse reactions, some of which can be serious.

Severe allergic reactions have been reported, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters.

The use of ibuprofen carries a warning for potential severe stomach bleeding, especially in patients with a history of stomach ulcers or bleeding problems. The risk is heightened in those taking anticoagulants, steroid medications, or other NSAIDs, including aspirin and naproxen. Patients should be advised to adhere strictly to dosing instructions, as exceeding the recommended dosage or duration of use increases the risk of gastrointestinal complications.

Additionally, ibuprofen is associated with an elevated risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced when the medication is used in higher doses or for extended periods.

Patients should be vigilant for signs of serious conditions, such as severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, and should seek medical attention promptly.

Patients are advised to discontinue use and consult a healthcare provider if they experience any signs of stomach bleeding, including feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain. Symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, also warrant immediate medical consultation.

If a patient does not achieve relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, they should seek medical advice. The presence of redness or swelling in the painful area or the emergence of any new symptoms should also prompt a consultation with a healthcare professional.

Before using ibuprofen, patients should consult a doctor if they have a history of stomach issues, have experienced serious side effects from pain relievers or fever reducers, are dehydrated, or have underlying health conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke. Additionally, patients with asthma or those taking diuretics should seek medical advice prior to use.

It is also recommended that patients under a doctor's care for any serious condition or those taking other medications consult with a healthcare provider or pharmacist before using ibuprofen.

Drug Interactions

There are currently no documented drug interactions associated with the use of this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Good Sense Childrens Ibuprofen (ibuprofen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 2 to 11 years may use this medication with specific dosing guidelines based on weight. For children weighing under 24 lb and those under 2 years of age, consultation with a doctor is advised before use. The recommended dosages for children aged 2 to 11 years are as follows:

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

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

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

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

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

It is important to note that this medication should not be used in children under 3 years of age unless directed by a healthcare professional. Parents and caregivers should consult a doctor if the child experiences a severe or persistent sore throat, or if the sore throat is accompanied by high fever, headache, nausea, or vomiting.

To ensure safety, this medication should be kept out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

The safety of ibuprofen during pregnancy has not been established. Ibuprofen is contraindicated in the third trimester of pregnancy due to the risk of premature closure of the ductus arteriosus in the fetus. The use of ibuprofen during pregnancy may pose risks to the fetus, including potential cardiovascular effects. Therefore, pregnant women should consult a healthcare provider before using ibuprofen.

Lactation

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

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have a history of kidney disease. It is essential to assess the patient's overall health status, including any comorbid conditions such as high blood pressure, heart disease, or liver cirrhosis, as these may influence the management of their renal function and the appropriateness of treatment. Monitoring and potential dosing adjustments may be necessary based on the patient's renal status to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment may experience altered pharmacokinetics of the medication due to compromised liver function. It is essential to assess the severity of liver impairment before initiating treatment.

In patients with liver cirrhosis, dosage adjustments may be necessary to avoid potential toxicity. Close monitoring of liver function tests is recommended throughout the treatment course to ensure safety and efficacy.

Additionally, patients with a history of significant cardiovascular conditions, such as high blood pressure or heart disease, as well as those with kidney disease or a history of stroke, should be evaluated carefully, as these factors may further complicate the management of their hepatic condition.

Overall, a thorough assessment of each patient's individual health status is crucial in determining the appropriate therapeutic approach for those with hepatic impairment.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Healthcare professionals should advise patients or caregivers to call the Poison Control Center at 1-800-222-1222 for guidance.

Prompt intervention is crucial in managing overdose situations, as timely medical support can significantly influence outcomes. Symptoms of overdose may vary depending on the substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care, monitoring of vital signs, and symptomatic treatment as necessary. It is essential for healthcare professionals to remain vigilant and act swiftly to mitigate potential complications associated with overdose.

Nonclinical Toxicology

No information is available regarding teratogenic effects. Similarly, there is no information provided concerning non-teratogenic effects. The insert does not contain any details related to nonclinical toxicology. Additionally, there is no information available regarding animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. Reports of allergic reactions have been documented, including hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Additionally, instances of stomach bleeding have been noted, particularly in patients with a history of stomach ulcers or bleeding problems, as well as those concurrently using anticoagulants or other nonsteroidal anti-inflammatory drugs (NSAIDs).

There is an increased risk of serious cardiovascular events, including heart attack, heart failure, and stroke, associated with NSAID use. Furthermore, reports of serious skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have been received. Cases of renal toxicity, including acute kidney injury, have also been reported in the postmarketing experience. Lastly, gastrointestinal adverse events, including perforation, ulceration, and bleeding, have been documented.

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.

Patients should be informed that they may experience burning sensations in the mouth or throat when taking the medication. To mitigate this, it is recommended to take the medication with food or water. Additionally, if patients experience stomach upset, they should take the medication with food or milk to help alleviate discomfort.

Storage and Handling

The product is supplied in a configuration that includes an NDC number for identification. It should be stored at a temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy.

Healthcare professionals are advised to inspect the product prior to use; it should not be utilized if the printed seal under the cap is broken or missing, as this may indicate potential tampering or contamination. Proper handling and storage conditions are essential to ensure the product remains safe and effective for patient use.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

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