Motrin

Description

NDC 50580-198-50 designates this concentrated Motrin® Infants' Drops, formulated for infants aged 6 months to 23 months. This oral suspension contains ibuprofen as the active ingredient, providing a dosage of 50 mg per 1.25 mL. It serves as a non-steroidal anti-inflammatory drug (NSAID) for pain relief and fever reduction, with effects lasting up to 8 hours. The product is dye-free, non-staining, and features an original berry flavor. It is packaged in a 1 fl oz (30 mL) bottle and is intended for use with the enclosed syringe.

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

This product is intended for pediatric use only, and healthcare professionals should ensure that dosing is based on the child's weight whenever possible. If weight is not available, age may be used as a guide.

Prior to administration, the product must be shaken well. The appropriate dose should be measured using the dosing device provided; no other measuring device should be utilized to ensure accuracy.

For children under 6 months of age, it is advised to consult a physician before administration. For children weighing between 12 to 17 pounds (approximately 6 to 11 months of age), the recommended dose is 1.25 mL. For those weighing between 18 to 23 pounds (approximately 12 to 23 months of age), the recommended dose is 1.875 mL.

The liquid should be dispensed slowly into the child's mouth, directed toward the inner cheek to facilitate swallowing. If necessary, doses may be repeated every 6 to 8 hours, but it is imperative not to exceed 4 doses in a 24-hour period.

Healthcare professionals should emphasize to caregivers the importance of adhering to the recommended dosing guidelines and not exceeding the directed amount.

Contraindications

Use of this product is contraindicated in the following situations:

• In patients with a history of allergic reactions to ibuprofen or any other pain reliever or fever reducer, due to the risk of severe allergic reactions.

• In patients undergoing heart surgery, as use immediately before or after such procedures may pose significant risks.

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, or naproxen). Additionally, exceeding the recommended dosage or duration of use increases this risk.

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

In cases of severe or persistent sore throat, particularly when accompanied by high fever, headache, nausea, or vomiting, immediate consultation with a healthcare provider is advised. 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 physician.

Healthcare providers should instruct caregivers to discontinue use and seek medical advice 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, symptoms indicative of heart problems or stroke, including 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 consultation is necessary. Any new symptoms that arise should also prompt a discussion with a healthcare professional.

In the event of an overdose, it is crucial to obtain emergency medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

Side Effects

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.

As an NSAID, ibuprofen carries a warning regarding the potential for 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, individuals using other NSAIDs (including aspirin, ibuprofen, or naproxen), and those who exceed the recommended dosage or duration of use.

Additionally, the use of NSAIDs, excluding aspirin, is associated with an increased 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.

Patients should be vigilant for severe or persistent sore throat symptoms, especially when accompanied by high fever, headache, nausea, or vomiting, as these may indicate a serious condition requiring prompt medical consultation. It is advised not to use ibuprofen for more than two days or to administer it to children under three years of age without a doctor's guidance.

Parents and caregivers should discontinue use and seek medical advice if the child exhibits signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing 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 the child does not experience relief within the first 24 hours of treatment, or if fever or pain worsens or persists beyond three days, medical consultation is recommended. Redness or swelling in the painful area or the emergence of any new symptoms should also prompt a discussion with a healthcare provider.

Before administering ibuprofen, it is advisable to consult a doctor if the child has a history of stomach issues, such as heartburn, has experienced serious side effects from pain relievers or fever reducers, is dehydrated, or has lost significant fluids due to vomiting or diarrhea. Additional caution is warranted for children with high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke, as well as those with asthma or those taking diuretics. It is also recommended to consult a doctor or pharmacist if the child is under medical care for any serious condition or is taking other medications.

Drug Interactions

Ibuprofen has the potential to induce severe allergic reactions, particularly in individuals with a known allergy to aspirin.

When considering the risk of gastrointestinal complications, the concomitant use of ibuprofen with anticoagulants or steroid medications significantly increases the likelihood of stomach bleeding. This risk is further amplified if the patient is also taking other nonsteroidal anti-inflammatory drugs (NSAIDs), including but not limited to aspirin, naproxen, or other prescription and nonprescription NSAIDs.

It is advisable for healthcare providers to consult with a physician if the patient is concurrently using a diuretic, as this may necessitate careful monitoring or dosage adjustments to mitigate potential adverse effects.

Packaging & NDC

Below are the non-prescription pack sizes of Motrin (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 healthcare professional. For infants under 6 months, consultation with a doctor is advised prior to use.

Dosing for children is as follows: for those weighing 12-17 lbs (6-11 months), the recommended dose is 1.25 mL; for children weighing 18-23 lbs (12-23 months), the dose is 1.875 mL. It is crucial to adhere to the recommended dosing guidelines, with a maximum of 4 doses per day.

In pediatric patients with a history of stomach ulcers or bleeding problems, there is an increased risk of stomach bleeding. Additionally, consultation with a healthcare provider is recommended for children with a history of stomach issues, high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma.

If a child does not experience relief within the first 24 hours of treatment, or if fever or pain persists for more than 3 days, a doctor should be consulted. Parents and caregivers should ensure that the medication is kept out of reach of children, and in the event of an overdose, immediate medical assistance or contact with a Poison Control Center is necessary.

Geriatric Use

There is no specific information regarding the use of Motrin Infants (ibuprofen suspension/drops) in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when considering the administration of this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects is advisable, given the lack of targeted data for this population.

Pregnancy

There are no specific statements regarding the use of Motrin Infants (ibuprofen) during pregnancy. The prescribing information does not mention any contraindications or risks associated with the use of ibuprofen in pregnant patients. Additionally, no dosage modifications for pregnant individuals are provided. The insert also does not include any special precautions regarding the use of ibuprofen during pregnancy. Healthcare professionals should consider the absence of data when advising women of childbearing potential and weigh the benefits against any potential risks.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the effects of ibuprofen on a nursing infant are not well studied; therefore, caution is advised. It is recommended to monitor the nursing infant for any adverse effects if the mother is taking ibuprofen.

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, liver cirrhosis, or a history of stroke, as these factors 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 period 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. 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

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions such as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Additionally, cases of stomach bleeding have been reported, particularly in patients with a history of stomach ulcers or bleeding problems, especially when concomitantly using other NSAIDs or blood thinners.

There is also an increased risk of heart attack, heart failure, and stroke associated with the use of NSAIDs. Furthermore, reports of severe or persistent sore throat, or sore throat accompanied by high fever, headache, nausea, and vomiting have been noted as serious conditions that require prompt medical consultation.

Patient Counseling

Advise patients to keep this medication out of reach of children to prevent accidental ingestion. Instruct them that in the event of an overdose, they should seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Inform patients that this medication should not be used if the child has a history of allergic reactions to ibuprofen or any other pain reliever or fever reducer. Additionally, it should not be administered right before or after heart surgery.

Patients should be made aware of the signs of potential stomach bleeding. They should stop use and consult a doctor if the child experiences any of the following symptoms: feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve.

Furthermore, patients should be advised to stop use and seek medical attention if the child exhibits 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 instructed to discontinue use and consult a doctor if the child does not experience relief within the first 24 hours of treatment, if fever or pain worsens or persists for more than three days, if there is redness or swelling in the painful area, or if any new symptoms arise.

When using this product, patients should be advised to take it with food or milk if stomach upset occurs. It is important for patients to consult a doctor before use if the stomach bleeding warning applies to their child or if the child has a history of stomach problems, such as heartburn.

Patients should also be encouraged to seek medical advice before use if the child has experienced serious side effects from pain relievers or fever reducers, has not been drinking fluids, or has lost a significant amount of fluid due to vomiting or diarrhea.

Additionally, patients should consult a doctor before use if the child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke, as well as if the child has asthma or is taking a diuretic.

Finally, patients should be advised to consult a doctor or pharmacist before use if the child is under medical care for any serious condition or is taking any other medications.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers, which should be referenced for identification. It is essential to store the product 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 tape or bottle wrap imprinted with "Sealed For Your Safety" is broken or missing, as this may indicate potential tampering or contamination. Proper handling and storage conditions are crucial to ensure the safety and effectiveness of the product.

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. Patients are advised to take the medication with food or milk if they experience stomach upset.

Clinicians should counsel patients to discontinue use and seek medical attention if a child exhibits signs of stomach bleeding or symptoms indicative of heart problems or stroke. Additionally, it is crucial to keep the medication out of reach of children, and in the event of an overdose, immediate medical assistance or contact with a Poison Control Center is necessary.

Drug Information (PDF)

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

View product document (PDF)