Good Neighbor Pharmacy Ibuprofen

Description

Children’s Ibuprofen Oral Suspension is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the relief of pain and reduction of fever in children aged 2 to 11 years. Each 5 mL dose contains 100 mg of ibuprofen. The formulation is alcohol-free and is presented in a berry flavor to enhance palatability. The product is packaged in a 4 fl oz (120 mL) bottle and provides relief that lasts up to 8 hours. This product is marketed under the GOOD NEIGHBOR PHARMACY® brand and is comparable to the active ingredient found in Children’s Motrin®.

Uses and Indications

This drug is indicated for the relief of minor aches and pains associated with the common cold, influenza, sore throat, headache, and toothache. Additionally, it is utilized to reduce fever.

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

Dosage and Administration

This product is intended for use in pediatric patients, and healthcare professionals should refer to the dosing chart to determine the appropriate dose based on the patient's weight or age. It is essential to shake the product well before each use. The enclosed dosing cup must be used for accurate measurement; no other dosing devices should be employed.

Dosing recommendations are as follows:

• For patients weighing under 24 lbs or under 2 years of age, the dose should be determined by a healthcare professional.

• For patients weighing 24-35 lbs (2-3 years), the recommended dose is 5 mL.

• For patients weighing 36-47 lbs (4-5 years), the recommended dose is 7.5 mL.

• For patients weighing 48-59 lbs (6-8 years), the recommended dose is 10 mL.

• For patients weighing 60-71 lbs (9-10 years), the recommended dose is 12.5 mL.

• For patients weighing 72-95 lbs (11 years), the recommended dose is 15 mL.

If necessary, doses may be repeated every 6-8 hours, but it is important not to exceed 4 doses in a 24-hour period. After each use, the dosing cup should be washed to ensure cleanliness. To maintain child resistance, the original bottle cap should be replaced securely after each use. It is critical to adhere to the prescribed dosing and not exceed the recommended amounts.

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 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 a risk of severe stomach bleeding. The likelihood of this adverse effect is increased 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 heightened when the medication is used in excess of the recommended dosage or for prolonged periods.

Severe or persistent sore throat, particularly when accompanied by high fever, headache, nausea, or 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.

Healthcare providers should advise caregivers to discontinue use and seek medical attention 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. Additionally, if symptoms indicative of heart problems or stroke arise—such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling—immediate medical evaluation is warranted.

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, further medical consultation is necessary. Any new symptoms that develop should also prompt a discussion with a healthcare professional.

In the event of an overdose, it is critical to seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

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, as a nonsteroidal anti-inflammatory drug (NSAID), carries a warning for potential severe stomach bleeding. The risk of this adverse reaction is heightened in patients with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroid medications, and individuals using other NSAIDs, including aspirin and naproxen. Additionally, the risk increases if the medication is taken in higher doses or for extended periods beyond the recommended guidelines.

Patients should also be aware of the increased risk of heart attack, heart failure, and stroke associated with NSAID use, excluding aspirin. These cardiovascular events can be fatal, particularly when the medication is used in excess or for longer durations than directed.

In clinical settings, patients presenting with severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, should be evaluated promptly, as these symptoms may indicate a serious condition. It is advised not to use ibuprofen for more than two days in such cases or to administer it to children under three years of age without medical guidance.

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

Before using ibuprofen, it is essential for patients to consult a doctor if they have a history of stomach issues, such as heartburn, or if they have experienced serious side effects from pain relievers or fever reducers. Patients who have not been adequately hydrated, have lost significant fluids due to vomiting or diarrhea, or have pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke should also seek medical advice prior to use. Additionally, patients with asthma or those taking diuretics should consult a healthcare professional before using this medication.

Lastly, it is recommended that patients under a doctor's care for any serious condition or those taking other medications discuss their use of ibuprofen with a healthcare provider or pharmacist.

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 patients with such allergies.

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 both prescription and over-the-counter options such as aspirin and naproxen.

Given these interactions, it is advisable for healthcare providers to closely monitor patients who are prescribed ibuprofen, especially those who are concurrently taking anticoagulants, steroids, or other NSAIDs. Consultation with a physician is recommended if the patient is on any additional medications to ensure safe and effective use of ibuprofen.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 3 years of age should not use this medication unless directed by a doctor. For children aged 2 to 11 years, dosing is based on weight and age, as follows:

• Under 24 lbs (under 2 years): consult a doctor

• 24-35 lbs (2-3 years): 5 mL

• 36-47 lbs (4-5 years): 7.5 mL

• 48-59 lbs (6-8 years): 10 mL

• 60-71 lbs (9-10 years): 12.5 mL

• 72-95 lbs (11 years): 15 mL

Dosing may be repeated every 6-8 hours, not to exceed 4 doses in a 24-hour period. It is essential to keep this medication out of reach of children. In the event of an overdose, immediate medical assistance or contact with a Poison Control Center is necessary.

Before administering this medication, healthcare professionals should advise parents to consult a doctor if the child has a history of allergic reactions to ibuprofen or other pain relievers, stomach issues, or serious side effects from pain relievers. Additional caution is warranted for children with dehydration, high blood pressure, heart disease, liver cirrhosis, kidney disease, a history of stroke, asthma, or those taking diuretics or other medications.

Parents should be instructed to discontinue use and seek medical advice if the child exhibits signs of stomach bleeding (e.g., faintness, vomiting blood, bloody or black stools, persistent stomach pain), symptoms of heart problems or stroke (e.g., chest pain, difficulty breathing, unilateral weakness, slurred speech, leg swelling), does not achieve relief within 24 hours, experiences worsening fever or pain lasting more than 3 days, shows redness or swelling in the painful area, or develops any new symptoms.

Geriatric Use

Elderly patients may not receive comprehensive guidance or warnings regarding the use of this product, as the labeling does not include specific directions for adult use. Healthcare providers should exercise caution when considering this product for geriatric patients, as the absence of detailed information may impact the safety and efficacy of treatment in this population. It is advisable to closely monitor elderly patients for any adverse effects and to consider potential dose adjustments based on individual patient needs and responses.

Pregnancy

The safety of ibuprofen during pregnancy has not been established. Ibuprofen is contraindicated in pregnancy, particularly during the third trimester, due to potential risks to the fetus. The use of ibuprofen during this period may pose risks, including potential cardiovascular effects on the developing fetus.

Pregnant women are advised to consult a healthcare provider before using ibuprofen to discuss potential risks and alternative treatment options.

Lactation

Nursing mothers should consult a doctor before using ibuprofen. There is a potential for excretion of ibuprofen in breast milk. The effects of ibuprofen on a nursing infant are not well studied; therefore, caution is advised. It is recommended to weigh the benefits against the risks when considering ibuprofen use while breastfeeding.

Renal Impairment

Patients with renal impairment may require careful consideration regarding dosing adjustments and monitoring. In particular, those with reduced kidney function should be assessed for potential changes in drug clearance. It is essential to evaluate the patient's overall health status, including any comorbid conditions such as high blood pressure, heart disease, liver cirrhosis, or a history of stroke, as these factors may further complicate the management of therapy in this population. Regular monitoring of renal function is recommended to ensure safe and effective use of the medication in patients with compromised renal status.

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 liver disease, such as cirrhosis, should be evaluated for any contraindications related to their hepatic condition. Regular assessment of clinical parameters and laboratory values is advised to manage any adverse effects effectively.

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 help can significantly influence outcomes. Symptoms of overdose may vary depending on the substance involved and the individual’s health status. Therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care, symptomatic treatment, and specific antidotes if applicable. Healthcare providers should remain vigilant and prepared to implement appropriate interventions based on the clinical presentation of the patient.

Nonclinical Toxicology

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

Postmarketing Experience

Allergic reactions, including hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters, have been reported in the postmarketing experience. Serious adverse reactions such as stomach bleeding, heart attack, and stroke have been noted, particularly in patients with a history of stomach ulcers or bleeding problems, or those concurrently taking anticoagulants or other nonsteroidal anti-inflammatory drugs (NSAIDs). Additionally, reports of headache, nausea, and vomiting as serious side effects have been documented. Cases of severe allergic reactions have been observed, especially in individuals with prior allergies to ibuprofen or other pain relievers and fever reducers.

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. It is recommended to administer the medication with food or milk if the patient experiences stomach upset.

Providers should inquire whether the patient has a history of stomach bleeding, as this may necessitate consultation with a doctor before use. Additionally, it is important to ask about any previous stomach problems, such as heartburn, and to confirm if the patient has experienced serious side effects from pain relievers or fever reducers.

Healthcare providers should also assess the patient's hydration status, particularly if the child has not been drinking fluids or has lost a significant amount of fluid due to vomiting or diarrhea. A thorough evaluation of the patient's medical history is essential, especially for those with high blood pressure, heart disease, liver cirrhosis, kidney disease, a history of stroke, or asthma. Consultation with a doctor is advised if the patient is taking a diuretic or is under care for any serious condition.

Before initiating treatment, providers should recommend that patients consult with a doctor or pharmacist if they are taking any other medications. Patients should be instructed to discontinue use and seek medical advice if they experience any signs of stomach bleeding, including feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain.

Furthermore, patients should be advised to stop use and consult a doctor if they do not achieve relief within the first 24 hours of treatment, if fever or pain worsens or persists beyond three days, if there is redness or swelling in the painful area, or if any new symptoms arise.

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 a controlled temperature range of 20-25°C (68-77°F). Freezing the product is strictly prohibited, as it may compromise its integrity and efficacy. Proper storage conditions must be maintained to ensure the product's quality and effectiveness throughout its shelf life.

Additional Clinical Information

The medication is administered orally, with a recommended dosing frequency of every 6-8 hours as needed, not to exceed four doses per day. Clinicians should advise patients to take the medication with food or milk if gastrointestinal upset occurs.

Patient counseling should emphasize the importance of keeping the medication out of reach of children and the necessity of seeking immediate medical assistance or contacting a Poison Control Center (1-800-222-1222) in the event of an overdose. Patients are instructed to use only the enclosed dosing cup for administration and to wash it after each use to ensure accurate dosing.

Drug Information (PDF)

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

View product document (PDF)