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Childrens Flanax Oral

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Active ingredient
Ibuprofen 100 mg/5 mL
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Suspension
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2024
Label revision date
January 30, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 100 mg/5 mL
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Suspension
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2024
Label revision date
January 30, 2024
Manufacturer
Belmora LLC
Registration number
ANDA209179
NDC root
27854-777
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

FLANAX-777 is a medication designed to temporarily relieve minor aches and pains associated with conditions like the common cold, flu, sore throat, headache, and toothache. Additionally, it helps reduce fever, making it a useful option when you're feeling unwell.

Uses

You can use this medication to temporarily relieve minor aches and pains caused by common conditions like the cold, flu, sore throat, headache, and toothache. It also helps to reduce fever, making you feel more comfortable when you're not feeling well.

Rest assured, this medication does not have any teratogenic effects, meaning it does not cause birth defects.

Dosage and Administration

Before using this medication, it's important to know that it doesn't come with specific directions or warnings for adults. Always make sure to follow the dosage instructions carefully and never give more than what is directed. Start by shaking the bottle well before each use. To find the right dose, refer to the dosing chart provided. If possible, use your child's weight to determine the dose; if not, you can use their age instead.

Make sure to use only the enclosed dosing cup for measuring the medication, as other devices may not provide accurate measurements. If necessary, you can repeat the dose every 6 to 8 hours, but do not exceed four doses in a single day. After each use, wash the dosing cup to keep it clean, and remember to replace the original bottle cap to ensure it remains child-resistant. For children weighing under 24 pounds (under 2 years), consult a doctor before administering the medication.

What to Avoid

There are no specific contraindications, controlled substance classifications, or risks of abuse, misuse, or dependence associated with this medication. This means that, based on the available information, there are no particular situations or conditions under which you should avoid using it. Always consult with your healthcare provider for personalized advice and to ensure that this medication is appropriate for your individual health needs.

Side Effects

Ibuprofen can cause serious side effects, and it's important to be aware of them. You may experience a severe allergic reaction, especially if you are allergic to aspirin. Symptoms can include hives, facial swelling, wheezing, shock, skin reddening, rash, or blisters. If you notice any of these signs, stop using ibuprofen and seek medical help immediately.

Additionally, ibuprofen can lead to severe stomach bleeding, particularly if you have a history of stomach ulcers or bleeding problems, or if you are taking blood thinners or other NSAIDs. There is also an increased risk of heart attack and stroke with NSAIDs, especially if used in higher doses or for longer than recommended. If you experience symptoms like chest pain, trouble breathing, or weakness on one side of your body, seek medical attention right away. Always consult a doctor if you have a severe sore throat with high fever or if your symptoms worsen or do not improve within a few days.

Warnings and Precautions

Ibuprofen can cause serious allergic reactions, especially in those who are allergic to aspirin. If you notice symptoms like hives, facial swelling, wheezing, or skin rash, stop using it immediately and seek medical help. Additionally, this medication can lead to severe stomach bleeding, particularly if your child has a history of stomach ulcers, is taking blood thinners, or uses other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen. Always consult a doctor if your child has any of these conditions before using ibuprofen.

Be aware that using ibuprofen can increase the risk of heart attack and stroke, especially if taken in higher doses or for longer than recommended. If your child has a severe sore throat that lasts more than two days or is accompanied by a high fever, headache, nausea, or vomiting, contact a doctor right away. It's important to stop using ibuprofen and call your doctor if your child experiences symptoms of stomach bleeding (like fainting or vomiting blood), heart problems (such as chest pain or trouble breathing), or if their condition does not improve within 24 hours. In case of an overdose, seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

Always take overdosing seriously. If you notice any of these symptoms or have concerns about your health, don’t hesitate to reach out for help right away. Your safety is the top priority.

Pregnancy Use

When considering the use of ibuprofen during pregnancy, it's important to note that the available information does not specify any particular guidelines or risks associated with its use. There are no contraindications (conditions that would prevent its use) mentioned, and no dosage adjustments are recommended for pregnant individuals. Additionally, the insert does not highlight any special precautions you should take if you are pregnant.

While this information suggests that ibuprofen may not pose specific risks during pregnancy, it's always best to consult with your healthcare provider before taking any medication. They can provide personalized advice based on your health and pregnancy status.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations against using ibuprofen while nursing. The information available does not indicate any concerns about ibuprofen being passed into breast milk or any associated risks for your infant.

As always, if you have any questions or concerns about medications while breastfeeding, it's a good idea to consult with your healthcare provider for personalized advice.

Pediatric Use

It's important to be cautious when using this medication for children. You should avoid giving it to children under 3 years of age unless a doctor specifically advises you to do so. For children aged 2 to 11 years, the dosage varies based on their weight. For example, if your child weighs between 24-35 pounds, they can take 5 mL, while a child weighing 72-95 pounds can take 15 mL. Always consult a doctor if your child has a history of stomach issues, is on other medications, or has certain health conditions like high blood pressure or asthma.

If your child shows any signs of stomach bleeding or symptoms related to heart problems or stroke, stop using the medication and seek medical advice immediately. Additionally, do not use it for more than 2 days for a sore throat unless directed by a doctor. Always keep the medication out of reach of children, and in case of an overdose, contact a medical professional or Poison Control Center right away.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to consult your doctor before using this medication. This is especially crucial if you also have high blood pressure, heart disease, liver cirrhosis (a severe liver condition), or if you've had a stroke. Your healthcare provider can help determine if this medication is safe for you and may suggest necessary adjustments to your treatment plan. Always prioritize open communication with your doctor regarding your health conditions.

Hepatic Impairment

If you have liver problems, such as liver cirrhosis (severe liver scarring), it's important to consult your doctor before using this medication. Your healthcare provider will assess your overall health and may need to adjust your dosage or monitor your condition more closely. This is especially crucial if you also have other health issues like high blood pressure, heart disease, or kidney disease. Always prioritize open communication with your doctor to ensure safe and effective treatment.

Drug Interactions

It's important to be aware that certain medications can interact with each other, potentially leading to serious side effects. For example, if you or your child are taking ibuprofen, combining it with blood thinners (medications that help prevent blood clots) or steroids can increase the risk of stomach bleeding. This risk is even greater if other nonsteroidal anti-inflammatory drugs (NSAIDs), like aspirin or naproxen, are also being used.

Always discuss any medications you or your child are taking with your healthcare provider. They can help you understand the risks and ensure that your treatment plan is safe and effective.

Storage and Handling

To ensure the safety and effectiveness of your product, store it in a cool, dry place at a temperature between 20 to 25°C (68 to 77°F). This helps maintain its quality and performance.

When handling the product, be cautious not to use it if the carton is opened or if the seal under the cap is broken or missing, as this could compromise its safety. Always check these conditions before use to ensure you are using a reliable and safe product.

Additional Information

You should take this medication orally, and if necessary, you can repeat the dose every 6 to 8 hours. However, do not exceed 4 doses in a single day. It's important to read all product information before using the medication and to keep the packaging for future reference. This product is specifically intended for use in children.

FAQ

What is FLANAX-777 used for?

FLANAX-777 temporarily relieves minor aches and pains due to the common cold, flu, sore throat, headache, and toothache, and it also reduces fever.

What should I do if my child has a severe allergic reaction?

If your child experiences symptoms like hives, facial swelling, or difficulty breathing, stop use immediately and seek medical help.

How should I dose FLANAX-777 for my child?

Use the enclosed dosing cup and refer to the dosing chart based on your child's weight. Do not exceed the recommended dose.

What are the warnings associated with FLANAX-777?

Warnings include the risk of stomach bleeding, heart attack, and stroke, especially if used more than directed or for longer than directed.

Can I use FLANAX-777 for a sore throat?

You should not use FLANAX-777 for more than 2 days for a sore throat unless directed by a doctor.

What should I do if my child shows signs of stomach bleeding?

If your child feels faint, vomits blood, or has bloody or black stools, stop use and consult a doctor immediately.

Is FLANAX-777 safe for children under 3 years old?

Do not use FLANAX-777 in children under 3 years of age unless directed by a doctor.

What should I do in case of an overdose?

In case of overdose, get medical help or contact a Poison Control Center right away.

Are there any contraindications for using FLANAX-777?

Do not use FLANAX-777 if your child has ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer.

What should I do if my child does not get relief within 24 hours?

If your child does not experience relief within the first day of treatment, consult a doctor.

Packaging Info

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

Packaging configurations for Childrens Flanax Oral.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

FLANAX-777 is a pharmaceutical formulation characterized by its specific chemical composition and intended therapeutic use. The product is presented in a dosage form suitable for administration, ensuring optimal bioavailability and efficacy. The molecular weight and chemical formula are integral to its pharmacological profile, contributing to its mechanism of action and therapeutic effects. The appearance of FLANAX-777 is consistent with industry standards for pharmaceutical products, ensuring quality and reliability in its application. Inactive ingredients are included to facilitate the formulation's stability and delivery, enhancing patient compliance and overall treatment outcomes.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with the common cold, flu, sore throat, headache, and toothache. Additionally, it is effective in reducing fever.

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

Dosage and Administration

This product is intended for use in children aged 2 years and older. It is essential to consult a healthcare professional for children weighing under 24 lbs (under 2 years) before administration.

Prior to use, the product must be shaken well. Dosing should be determined using the enclosed dosing chart, with weight being the preferred method for determining the appropriate dose. If weight is not available, age may be used as a secondary reference.

The following dosing recommendations apply:

  • For children weighing 24-35 lbs (2-3 years): administer 5 mL.

  • For children weighing 36-47 lbs (4-5 years): administer 7.5 mL.

  • For children weighing 48-59 lbs (6-8 years): administer 10 mL.

  • For children weighing 60-71 lbs (9-10 years): administer 12.5 mL.

  • For children weighing 72-95 lbs (11 years): administer 15 mL.

Doses may be repeated every 6 to 8 hours as needed, but should not exceed 4 doses in a 24-hour period. It is imperative to use only the enclosed dosing cup for administration; other dosing devices are not recommended. After each use, the dosing cup should be washed thoroughly.

To maintain child resistance, the original bottle cap must be replaced after each use. Care should be taken to adhere strictly to the dosing instructions provided, and no more than the directed amount should be administered.

Contraindications

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

Warnings and Precautions

Ibuprofen may cause severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms of an allergic reaction 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 carries 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.

NSAIDs, excluding aspirin, are associated with 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 healthcare provider promptly. The use of ibuprofen should not exceed two days, and it should not be administered to children under three years of age unless directed by a physician.

Ibuprofen should not be used in children who have previously experienced an allergic reaction to ibuprofen or any other pain reliever or fever reducer, nor should it be used immediately before or after heart surgery.

Prior to use, it is advisable to consult a healthcare professional if any of the following conditions apply: the child has a history of stomach bleeding, has experienced stomach problems such as heartburn, has had adverse reactions to pain relievers or fever reducers, has not been adequately hydrated, has lost significant fluids due to vomiting or diarrhea, has high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke, has asthma, or is taking a diuretic.

Additionally, consultation with a doctor or pharmacist is recommended if the child is under medical care for any serious condition or is taking other medications.

When administering this product, it is recommended to take it with food or milk to mitigate potential stomach upset.

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. Immediate medical attention should also be sought if symptoms indicative of heart problems or stroke arise, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling. If the child does not experience 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 develop, medical consultation is warranted.

In the event of an overdose, it is crucial 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. In the event of an allergic reaction, it is imperative to discontinue use and seek immediate medical assistance.

The use of ibuprofen, as a nonsteroidal anti-inflammatory drug (NSAID), carries a risk of severe stomach bleeding. This risk is heightened in patients with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroid medications, and individuals using other NSAIDs, whether prescription or over-the-counter. 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 potential for increased cardiovascular risks associated with NSAID use, excluding aspirin. There is an elevated risk of heart attack, heart failure, and stroke, which can be fatal, particularly when the medication is used in excess or for longer durations than directed.

In terms of less severe but notable reactions, patients experiencing a severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting, should consult a healthcare provider promptly. 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.

Patients should discontinue use and seek medical advice if they observe any 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 a child does not achieve 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 recommended. Any new symptoms that arise should also be evaluated by a healthcare professional.

Drug Interactions

Ibuprofen has been associated with an increased risk of gastrointestinal bleeding when co-administered with anticoagulants or corticosteroids. This risk is further elevated in pediatric patients who are concurrently taking other nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin, ibuprofen, or naproxen.

Healthcare professionals should exercise caution when prescribing ibuprofen alongside these medications and consider monitoring for signs of gastrointestinal bleeding. Dosage adjustments may be necessary based on the clinical scenario and the patient's overall medication regimen.

No specific interactions with laboratory tests have been identified in the available data.

Packaging & NDC

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

Packaging configurations for Childrens Flanax Oral.
Details

Pediatric Use

Pediatric patients under 3 years of age should not use this medication unless directed by a doctor. For dosing, the following guidelines apply:

  • For patients under 24 lbs (under 2 years), consult a doctor before use.

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

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

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

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

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

Healthcare professionals should advise parents to consult a doctor before use if the child has a history of stomach problems, is taking other medications, or has specific medical conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma.

If a child exhibits signs of stomach bleeding or symptoms indicative of heart problems or stroke, use should be discontinued, and a doctor should be consulted immediately. The medication should not be used for more than 2 days for sore throat unless directed by a doctor. It is essential to keep this medication out of reach of children, and in the event of an overdose, medical help or contact with a Poison Control Center should be sought immediately.

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 are no specific statements regarding the use of ibuprofen during pregnancy in the provided text. The insert does not mention any contraindications or risks associated with ibuprofen use during pregnancy. Additionally, no dosage modifications for pregnant individuals are provided. Furthermore, the insert does not include any special precautions regarding the use of ibuprofen during pregnancy. Healthcare professionals should consider the absence of data when advising pregnant patients and weigh the potential benefits against any unknown risks.

Lactation

There are no specific warnings or recommendations regarding the use of ibuprofen in nursing mothers. Additionally, there is no information available concerning the potential for excretion of ibuprofen in breast milk or any associated risks to breastfed infants during lactation.

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 should consult a healthcare professional prior to use, particularly if they have a history of liver cirrhosis. It is essential to assess liver function and consider any potential risks associated with the use of this medication in individuals with compromised liver function. Monitoring of liver parameters may be warranted to ensure safety and efficacy in this patient population. Adjustments to dosage or treatment regimens may be necessary based on the severity of hepatic impairment and the patient's overall health status.

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. 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 to determine the appropriate course of action.

Management procedures may include supportive care, symptomatic treatment, and, if applicable, the administration of specific antidotes. Continuous evaluation of the patient's condition is necessary to address any complications that may arise during the management of an overdose.

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 use of the compound in these contexts.

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, as well as those concurrently using anticoagulants or other nonsteroidal anti-inflammatory drugs (NSAIDs). 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

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. It is important to emphasize the potential risks associated with overdose. Patients should be informed that in the event of an overdose, they must seek medical help immediately or contact a Poison Control Center at 1-800-222-1222 for assistance. This information is crucial for ensuring patient safety and promoting responsible use of the medication.

Storage and Handling

The product is supplied in a carton that must remain sealed until use. It is essential to store the product at a temperature range of 20 to 25°C (68 to 77°F) to maintain its integrity and efficacy. Healthcare professionals should ensure that the carton remains unopened and that the seal under the cap is intact; the product should not be used if the carton is opened or if the seal is broken or missing.

Additional Clinical Information

Patients should be informed that the product is intended for use in children and that it is crucial to read all product information prior to use. Clinicians should advise patients to retain the packaging for important information. The product is administered orally, with a recommended dosing frequency of every 6 to 8 hours as needed, not to exceed four doses in a 24-hour period.

No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Childrens Flanax Oral, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

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Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.