Childrens Ibuprofen Oral Suspension

Description

NDC 69618-078-54 designates this product as a Children's Ibuprofen Oral Suspension, formulated for use in children aged 2 to 11 years. This oral suspension is a nonsteroidal anti-inflammatory drug (NSAID) containing 100 mg of ibuprofen per 5 mL. It serves as a pain reliever and fever reducer, providing relief that lasts up to 8 hours. The formulation is dye-free and features an original berry flavor. Each bottle contains 4 fl oz (118 mL) of the suspension.

Uses and Indications

This drug is indicated for the relief of pain and reduction of fever in pediatric patients aged 2 to 11 years. It is formulated as an oral suspension containing 100 mg of the active ingredient per 5 mL. The analgesic and antipyretic effects of this medication can last for up to 8 hours.

Limitations of Use: There are no known teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Healthcare professionals should refer to the Dosing Chart for specific dosage information regarding the administration of the medication.

For the route, method, and frequency of administration, detailed instructions are not provided in the text. It is essential to consult the Dosing Chart for comprehensive guidance on these aspects to ensure proper administration and dosing accuracy.

Contraindications

Use of this product is contraindicated in children with a history of gastrointestinal issues, including heartburn. It should not be administered to children who have experienced adverse reactions to pain relievers or fever reducers. Additionally, contraindications include children who are dehydrated, either due to inadequate fluid intake or significant fluid loss from vomiting or diarrhea.

Children with pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke should not use this product. It is also contraindicated in children with asthma or those currently taking a diuretic.

If any signs of stomach bleeding occur, such as faintness, vomiting blood, bloody or black stools, or persistent stomach pain, discontinue use and consult a physician. Similarly, if symptoms indicative of heart problems or stroke arise, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, medical advice should be sought immediately.

Discontinue use if the child does not experience relief within 24 hours, if fever or pain worsens or persists beyond three days, if there is redness or swelling in the affected area, or if any new symptoms develop.

Warnings and Precautions

Ibuprofen may cause severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions can 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 is associated with an increased risk of severe stomach bleeding. The likelihood of this adverse effect is heightened in children who have a history of stomach ulcers or bleeding disorders, are concurrently taking anticoagulants or steroid medications, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), or exceed the recommended dosage or duration of treatment.

Healthcare professionals should be aware that the use of NSAIDs, excluding aspirin, is linked to 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 extended periods.

Severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, and vomiting, may indicate a serious condition. In such cases, it is essential to consult a physician promptly. 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.

Ibuprofen should not be used in children who have a history of allergic reactions to ibuprofen or any other pain reliever or fever reducer. Additionally, it is contraindicated for use immediately before or after heart surgery.

In the event of an overdose, immediate medical attention is required. Healthcare providers should advise caregivers to contact a Poison Control Center at 1-800-222-1222 without delay.

Discontinuation of ibuprofen is warranted, and a physician should be consulted if the child exhibits any signs of stomach bleeding, such as feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Furthermore, if symptoms indicative of heart problems or stroke arise—such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling—medical evaluation is necessary.

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, or if any new symptoms develop, it is crucial to seek medical advice.

Side Effects

Patients may experience a range of adverse reactions associated with the use of ibuprofen, which can vary in seriousness and frequency.

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, steroids, or other NSAIDs, as well as in patients who exceed the recommended dosage or duration of use. Signs of stomach bleeding may include faintness, vomiting blood, bloody or black stools, and persistent stomach pain.

Additionally, there is an increased risk of heart attack, heart failure, and stroke associated with NSAID use, excluding aspirin. This risk escalates with higher doses or prolonged use. Patients should be vigilant for symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling.

Patients are advised to discontinue use and consult a healthcare provider if they do not achieve relief within the first 24 hours of treatment, if fever or pain worsens or persists beyond three days, if redness or swelling occurs in the affected area, or if any new symptoms arise.

Specific warnings also apply to children, including the recommendation to avoid use in those under three years of age unless directed by a physician, and to seek medical advice for severe or persistent sore throat accompanied by high fever, headache, nausea, or vomiting.

Additional considerations include the potential for adverse reactions in children with a history of stomach issues, dehydration, high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma, as well as those taking diuretics. It is crucial for patients to be aware of these risks and to communicate any relevant medical history to their healthcare provider prior to using ibuprofen.

Drug Interactions

Ibuprofen has the potential to induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. This risk necessitates careful consideration when prescribing ibuprofen to such patients.

In terms of pharmacodynamic interactions, the concomitant use of ibuprofen with anticoagulants or steroid medications significantly increases the risk of gastrointestinal bleeding. This risk is further compounded when ibuprofen is taken alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including prescription and nonprescription options such as aspirin and naproxen.

It is advisable for healthcare providers to consult with a doctor or pharmacist prior to administering ibuprofen if the patient is currently taking any other medications. This precaution is essential to ensure safe and effective use of ibuprofen, particularly in pediatric populations. Monitoring for signs of gastrointestinal distress is recommended in patients receiving these combinations.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 2 to 11 years may be treated with this medication; however, it is contraindicated in children under 3 years of age unless specifically directed by a healthcare professional.

Healthcare providers should be consulted promptly if a pediatric patient presents with a severe or persistent sore throat, especially if accompanied by high fever, headache, nausea, or vomiting. The medication should not be administered to children with a known allergy to ibuprofen or any other pain reliever or fever reducer. Additionally, it is contraindicated in patients with a history of gastrointestinal issues, such as heartburn, or those who have not been adequately hydrated due to vomiting or diarrhea.

This medication is also not recommended for children with high blood pressure, heart disease, liver cirrhosis, kidney disease, a history of stroke, or asthma. Prior to use, it is advisable to consult a healthcare provider if the child is under treatment for any serious medical condition or is taking other medications.

Dosing should be based on the child's weight; if weight is not available, age may be used as a guide. Doses may be repeated every 6 to 8 hours, but should not exceed four doses in a 24-hour period.

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

There is no specific mention of pregnancy use, safety concerns, dosage modifications, or special precautions regarding the use of ibuprofen during pregnancy in the provided text. Healthcare professionals should consider the lack of data when prescribing ibuprofen to pregnant patients and weigh the potential risks and benefits. It is advisable to exercise caution and to discuss any concerns with patients who are pregnant or planning to become pregnant.

Lactation

There are no specific statements regarding the use of this medication in lactating mothers. Additionally, there are no known data on excretion in breast milk or effects on breastfed infants. Healthcare professionals should consider the absence of information when advising lactating mothers about the use of this medication.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring of these patients.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

Overdosage of ibuprofen can lead to significant health risks and serious harm. Healthcare professionals should be aware of the potential symptoms associated with an overdose, which may include nausea, vomiting, stomach pain, drowsiness, and headache.

In the event of an overdose, it is crucial to seek immediate medical attention. Healthcare providers should advise patients or caregivers to contact a Poison Control Center for further guidance and management. Prompt intervention is essential to mitigate the effects of ibuprofen overdosage and ensure patient safety.

Nonclinical Toxicology

No teratogenic effects have been identified in the available data. Additionally, there is no information regarding non-teratogenic effects. The nonclinical toxicology section does not provide any specific details. Furthermore, there is no information available concerning animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified a range of adverse reactions associated with the use of the product. Reports indicate occurrences of allergic reactions, which may manifest as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters.

Severe gastrointestinal events, including stomach bleeding, have been particularly noted in children with a history of stomach ulcers or bleeding disorders, as well as in individuals taking blood thinners, steroids, or other nonsteroidal anti-inflammatory drugs (NSAIDs).

There is an increased risk of cardiovascular events, including heart attack, heart failure, and stroke, associated with NSAID use. Serious side effects have been reported, with symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, and leg swelling.

Additional adverse reactions may include symptoms suggestive of stomach bleeding, such as feeling faint, vomiting blood, passing bloody or black stools, and persistent stomach pain.

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 instructed to discontinue use and consult a doctor if the child exhibits any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve.

Additionally, healthcare providers should inform patients to stop use and seek medical advice if the child shows symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or swelling in the legs.

Patients should also be made aware that 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 there is redness or swelling in the affected area, they should consult a doctor. The appearance of any new symptoms should also prompt a discussion with a healthcare professional.

It is important for healthcare providers to remind patients to consult a doctor or pharmacist before using this product if the child is under medical care for any serious condition or is taking other medications.

Finally, patients should be advised to take the product with food or milk if stomach upset occurs during use.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers. 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 packaging prior to use; the product should not be utilized if the carton is opened or if the printed bottle neckband is broken or missing. 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 Childrens Ibuprofen Oral Suspension, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)