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Dg Health Ibuprofen

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Active ingredient
Ibuprofen 50 mg/1.25 mL
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Suspension/ Drops
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2010
Label revision date
May 15, 2025
Active ingredient
Ibuprofen 50 mg/1.25 mL
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Suspension/ Drops
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2010
Label revision date
May 15, 2025
Manufacturer
Dolgencorp, LLC
Registration number
ANDA075217
NDC root
55910-255

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Drug Overview

Ibuprofen Oral Suspension is a concentrated liquid medication designed for children aged 6 to 23 months. It contains 50 mg of ibuprofen (a type of nonsteroidal anti-inflammatory drug, or NSAID) per 1.25 mL and is used to relieve minor aches and pains, such as those caused by the common cold, flu, sore throat, headaches, and toothaches. Additionally, it helps reduce fever and can provide relief for up to 8 hours.

This product is gluten-free, dye-free, and has a pleasant berry flavor, making it easier for young children to take. It is important to use the enclosed syringe for accurate dosing. Ibuprofen Oral Suspension is comparable to the active ingredient found in Motrin® Infants’ Drops.

Uses

You can use this medication to help reduce fever and relieve minor aches and pains. It’s effective for discomfort caused by common conditions such as the cold, flu, sore throat, headaches, and toothaches.

This means that if you're feeling under the weather or dealing with everyday aches, this medication can provide some relief to help you feel better.

Dosage and Administration

Before using this product, it's important to note that it does not come with specific directions or warnings for adults. Always make sure to follow the recommended dosage and never exceed the amount directed. To prepare the medication, shake the bottle well before use. You can find the right dose by referring to the dosing chart, which suggests using your child's weight for the most accurate measurement. If weight isn't available, you can use their age instead.

When measuring the dose, use the dosing device that comes with the product, as other devices may not provide accurate measurements. For administration, slowly dispense the liquid into your child's mouth, aiming for the inner cheek. If necessary, you can repeat the dose every 6 to 8 hours, but remember not to give more than four doses in a single day. For infants under 6 months, it's best to consult a doctor before giving this medication.

What to Avoid

It's important to be cautious when considering this medication for your child. You should not use it if your child has ever had an allergic reaction to ibuprofen or any other pain reliever or fever reducer. Additionally, avoid using this medication right before or after heart surgery, as it can pose serious risks in these situations.

Always prioritize your child's safety by following these guidelines closely. If you have any concerns or questions about using this medication, consult with a healthcare professional for personalized advice.

Side Effects

Ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. Signs of an allergic reaction may include hives, facial swelling, wheezing (asthma), shock, skin reddening, rash, or blisters. Additionally, this medication carries a risk of severe stomach bleeding, especially if your child has a history of stomach ulcers, is taking blood thinners or steroids, or uses other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen.

There is also an increased risk of heart attack and stroke associated with NSAIDs, which can be life-threatening, particularly if used in higher doses or for extended periods. If your child experiences symptoms such as fainting, vomiting blood, or has bloody or black stools, seek medical attention immediately. It's important to consult a doctor if your child has a severe sore throat with high fever, or if symptoms worsen or persist beyond a few days. Always check with a healthcare professional before use if your child has any underlying health conditions or is taking other medications.

Warnings and Precautions

Ibuprofen can cause serious allergic reactions, especially if you are allergic to aspirin. Symptoms may include hives, facial swelling, wheezing, shock, skin reddening, rash, or blisters. If you experience any of these symptoms, stop using ibuprofen and seek medical help immediately.

This medication can also lead to severe stomach bleeding, particularly if you have a history of stomach ulcers or bleeding problems, are taking blood thinners or steroids, or are using other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen. Additionally, using ibuprofen for longer than directed increases the risk of heart attack and stroke, which can be fatal. If you notice signs of stomach bleeding, such as feeling faint, vomiting blood, or having black stools, or if you experience chest pain, trouble breathing, or weakness, stop using ibuprofen and contact your doctor right away.

For children, do not use ibuprofen for more than two days without a doctor's guidance, especially if they are under three years old. If your child does not feel better within 24 hours, if their fever or pain worsens or lasts more than three days, or if any new symptoms appear, consult a doctor. 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 err on the side of caution—if you notice any concerning symptoms or if you’re unsure, don’t hesitate to reach out for help. Your safety is the top priority, so getting prompt medical attention is essential.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of ibuprofen has not been established. In fact, ibuprofen is not recommended during pregnancy, especially in the third trimester, as it may pose risks to your developing baby, including potential cardiovascular effects.

Before taking ibuprofen, you should consult your healthcare provider, as they may need to adjust the dosage or suggest alternative pain relief options. It's best to avoid using ibuprofen unless your doctor specifically advises you to do so. Your health and the health of your baby are the top priority, so always seek professional guidance when it comes to medication during pregnancy.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to consult your doctor before using this product. There is a possibility that the ingredients may pass into your breast milk, which could pose risks to your infant. Therefore, exercising caution is essential when considering this medication while nursing. Always prioritize your health and your baby's safety by discussing any concerns with your healthcare provider.

Pediatric Use

When considering this medication for your child, it's important to note that it should not be used in children under 3 years of age unless specifically directed by a doctor. For children aged 6 months to 23 months, the dosage varies based on weight, so consult the dosing chart: infants under 6 months should always check with a doctor, while those weighing 12-17 lbs (6-11 months) can take 1.25 mL, and those weighing 18-23 lbs (12-23 months) can take 1.875 mL.

Before giving this medication, consult your child's doctor if they have a history of stomach issues, have not been drinking fluids, or have lost fluids due to vomiting or diarrhea. It's also crucial to check with a doctor if your child has high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or is taking a diuretic. Do not use the medication for more than 2 days, and if your child shows any signs of stomach bleeding or does not find relief within 24 hours, stop use and seek medical advice immediately.

Geriatric Use

When it comes to using Ibuprofen, there are no specific guidelines or dosage adjustments for older adults mentioned in the drug insert. This means that, generally, elderly patients can use Ibuprofen without special considerations or safety concerns that differ from younger adults.

However, it's always important to consult with a healthcare provider before starting any new medication, especially if you have other health conditions or are taking other medications. Your doctor can help ensure that Ibuprofen is safe and appropriate for your individual health needs.

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 whether any adjustments to your dosage or monitoring are necessary. Always prioritize your health and communicate openly with your doctor about your medical history.

Hepatic Impairment

If you have liver problems, such as liver cirrhosis (severe scarring of the liver), it's important to be aware of how this may affect your treatment. Your healthcare provider will need to monitor your liver function closely, which involves checking specific tests that measure how well your liver is working. Depending on the severity of your liver condition, they may adjust your medication dosage to ensure it's safe and effective for you.

Additionally, if you have other health issues like high blood pressure, heart disease, or kidney disease, these can also influence your treatment plan. Always communicate openly with your healthcare team about your liver health and any other medical conditions you have, so they can provide the best care tailored to your needs.

Drug Interactions

It's important to be aware of potential interactions when taking medications like ibuprofen. If you or your child are allergic to aspirin, using ibuprofen could lead to severe allergic reactions. Additionally, if your child is on blood thinners (medications that help prevent blood clots) or steroids, the risk of stomach bleeding increases. This risk is also heightened if they are taking other nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin or naproxen.

Always consult with a healthcare provider if your child is taking a diuretic (a medication that helps remove excess fluid from the body). Discussing all medications and any lab tests with your doctor is crucial to ensure safety and avoid serious side effects.

Storage and Handling

To ensure the best performance and safety of your product, store it at a temperature between 20-25°C (68-77°F). It's important to avoid freezing the product, as this can damage it. Before use, check the printed neckband; do not use the product if it is broken or missing, as this could compromise safety.

Handle the product with care, following these storage guidelines to maintain its integrity. Proper storage and handling will help ensure that you can use the product safely and effectively.

Additional Information

You should take this medication orally, dispensing the liquid slowly into your child's mouth toward the inner cheek. If necessary, you can repeat the dose every 6 to 8 hours, but do not exceed four doses in a day. To help prevent stomach upset, consider giving it with food or milk.

Always keep this medication out of reach of children. In the event of an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

FAQ

What is Ibuprofen Oral Suspension used for?

Ibuprofen Oral Suspension is used to reduce fever and relieve minor aches and pains due to the common cold, flu, sore throat, headaches, and toothaches.

What is the recommended dosage for children?

For children aged 6-11 months weighing 12-17 lbs, the dose is 1.25 mL. For children aged 12-23 months weighing 18-23 lbs, the dose is 1.875 mL. Always consult the dosing chart and use the provided syringe.

Are there any warnings associated with Ibuprofen?

Yes, Ibuprofen may cause severe allergic reactions, stomach bleeding, and increase the risk of heart attack and stroke. Consult a doctor if your child has a history of stomach problems or is taking other medications.

Can I use Ibuprofen if my child is under 3 years old?

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

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

If your child feels faint, vomits blood, has bloody or black stools, or has stomach pain that does not improve, stop use and consult a doctor immediately.

Is it safe to use Ibuprofen during pregnancy?

The safety of Ibuprofen during pregnancy has not been established, and it is contraindicated, especially during the third trimester. Consult a healthcare provider before use.

What should I do in case of an overdose?

In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

How should I store Ibuprofen Oral Suspension?

Store Ibuprofen Oral Suspension at 20-25°C (68-77°F) and do not freeze. Ensure the printed neckband is intact before use.

Packaging Info

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

Packaging configurations for Dg Health Ibuprofen.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Ibuprofen Oral Suspension is a non-steroidal anti-inflammatory drug (NSAID) formulated as a concentrated drop solution. Each 1.25 mL dose contains 50 mg of ibuprofen, providing effective pain relief and fever reduction. The product is presented in a 1 FL OZ (30 mL) bottle and is designed for use with the enclosed syringe to ensure accurate dosing.

This formulation is gluten-free, dye-free, and does not contain high fructose corn syrup. It is non-staining and features a berry flavor for palatability. The effects of the suspension may last up to 8 hours.

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 does not contain directions or complete warnings for adult use. Healthcare professionals should ensure that the dosage administered does not exceed the recommended limits.

Prior to administration, the product must be shaken well. The appropriate dose can be determined using the dosing chart provided below. When possible, dosing should be based on the child's weight; if weight is not available, age may be used as a guide.

Dosing should be measured using the dosing device provided with the product; other devices should not be used to ensure accurate dosing. The liquid should be dispensed slowly into the child’s mouth, directed toward the inner cheek.

If necessary, doses may be repeated every 6 to 8 hours, but the total daily administration should not exceed four doses.

Dosing Chart:

  • For children under 6 months of age and weighing less than 12 lbs, consult a physician before use.

  • For children weighing 12-17 lbs (approximately 6-11 months of age), the recommended dose is 1.25 mL.

  • For children weighing 18-23 lbs (approximately 12-23 months of age), the recommended dose is 1.875 mL.

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 carries a 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 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 associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk escalates with higher doses or prolonged use beyond the recommended guidelines.

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. Ibuprofen should not be used for more than two days or 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, further 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 critical to seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product. Serious adverse reactions include severe allergic reactions, which may manifest as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, or blisters, particularly in individuals with a known allergy to aspirin.

The use of this product, which contains a nonsteroidal anti-inflammatory drug (NSAID), carries a warning for severe stomach bleeding. The risk of this serious adverse reaction is heightened in patients with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroid medications, or those using other NSAIDs, including aspirin and naproxen. Additionally, prolonged use or exceeding the recommended dosage increases the likelihood of stomach bleeding.

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, and the risk escalates with higher doses or extended duration of use.

Common adverse reactions may include severe or persistent sore throat, especially when accompanied by high fever, headache, nausea, or vomiting. Such symptoms warrant prompt medical consultation.

Patients are advised to discontinue use and seek medical attention 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 necessitate immediate medical evaluation.

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 consult a healthcare professional. Redness or swelling in the painful area or the emergence of any new symptoms should also prompt medical advice.

Before using this product, it is essential for patients to consult a healthcare provider if they have a history of stomach problems, 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 guidance. Additionally, patients with asthma or those taking diuretics should consult a healthcare professional prior to use.

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 pediatric patients, the concomitant use of ibuprofen with anticoagulants or steroid medications significantly increases the risk of gastrointestinal bleeding. Therefore, it is advisable to monitor these patients closely for any signs of bleeding and to consider alternative pain management strategies if necessary.

Additionally, the risk of stomach bleeding is further elevated when ibuprofen is used alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as aspirin and naproxen. Clinicians should exercise caution and evaluate the necessity of combining these medications.

For children who are prescribed diuretics, it is recommended to consult a healthcare professional prior to initiating ibuprofen therapy. This consultation is essential to assess potential interactions and to ensure safe and effective treatment.

Packaging & NDC

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

Packaging configurations for Dg Health Ibuprofen.
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: infants under 6 months should consult a doctor before use; for those aged 6 to 11 months weighing 12-17 lbs, the recommended dose is 1.25 mL; and for children aged 12 to 23 months weighing 18-23 lbs, the recommended dose is 1.875 mL.

Healthcare professionals should advise parents to consult a doctor if the child has a history of stomach problems, such as heartburn, or if the child has not been drinking fluids or has experienced significant fluid loss due to vomiting or diarrhea. Additional caution is warranted for children with high blood pressure, heart disease, liver cirrhosis, kidney disease, a history of stroke, or asthma. It is also important to consult a doctor if the child is taking a diuretic or is under care for any serious condition.

The medication should not be used for more than 2 days, and if the child experiences any signs of stomach bleeding—such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain—use should be discontinued immediately, and a doctor should be consulted. If the child does not achieve relief within the first 24 hours of treatment, parents should also stop use and seek medical advice.

Geriatric Use

Elderly patients do not have specific geriatric use considerations, dosage adjustments, or safety concerns noted in the prescribing information for Ibuprofen. Therefore, standard dosing guidelines may be applied to this population without modification. However, healthcare providers should remain vigilant in monitoring for any potential adverse effects, as the pharmacokinetics of medications can vary in geriatric patients. It is advisable to assess each elderly patient individually, considering their overall health status and any concomitant medications that may influence the safety and efficacy of Ibuprofen.

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 pregnancy may pose risks, including potential cardiovascular effects on the developing fetus.

Pregnant women should avoid using ibuprofen unless specifically directed by a healthcare professional. It is essential for healthcare providers to be consulted prior to use, as dosage modifications may be necessary based on individual circumstances.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and caution is advised when administering to nursing mothers due to the potential risk to the infant.

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, including those with liver cirrhosis, may require careful consideration when being prescribed this medication. Due to the potential for altered pharmacokinetics in individuals with compromised liver function, dosage adjustments may be necessary.

Monitoring of liver function is recommended for patients with hepatic impairment to ensure safety and efficacy. Clinicians should assess liver enzymes and other relevant parameters regularly to evaluate the patient's response to treatment and to identify any potential adverse effects related to liver function.

Additionally, patients with a history of significant comorbidities such as high blood pressure, heart disease, kidney disease, or a history of stroke should be monitored closely, as these conditions may further complicate the management of their hepatic impairment.

It is essential for healthcare providers to weigh the benefits and risks of therapy in this population and to adjust treatment plans accordingly.

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 are advised to call the Poison Control Center at 1-800-222-1222 for guidance on managing the situation.

Prompt intervention is crucial in mitigating potential adverse effects associated with an overdose. Symptoms 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 and symptomatic treatment, tailored to the specific clinical presentation of the patient. Continuous monitoring and evaluation are essential to ensure patient safety and effective recovery.

Nonclinical Toxicology

No teratogenic effects have been observed in the studies conducted. Additionally, there are no reported non-teratogenic effects. The available data does not provide any specific details regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. These events have been documented in the context of postmarketing surveillance and are included for informational purposes.

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 encourage patients to consult a doctor prior to use if the child has a history of stomach issues, such as heartburn, or if there is a concern regarding stomach bleeding. Additionally, it is important to discuss the child's fluid intake; patients should be advised to consult a doctor if the child has not been drinking fluids or has lost a significant amount of fluid due to vomiting or diarrhea.

Healthcare providers should also inquire about the child's medical history, specifically if there are any existing conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke. If the child has asthma or is taking a diuretic, a consultation with a doctor is warranted before use.

Furthermore, patients should be encouraged to speak with a doctor or pharmacist if the child is under care for any serious condition or is currently taking any other medications. This ensures a comprehensive understanding of the child's health status and potential interactions.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate 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. Freezing the product is strictly prohibited, as it may compromise its quality.

Healthcare professionals should ensure that the product is not used if the printed neckband is broken or missing, as this may indicate tampering or compromise of the product's safety. Proper handling and adherence to these storage conditions are crucial for optimal product performance.

Additional Clinical Information

The medication is administered orally, with clinicians advised to dispense the liquid slowly into the child’s mouth, directing it toward the inner cheek. Dosing may be repeated every 6-8 hours as needed, but should not exceed four doses in a 24-hour period.

Patients should be counseled to administer the medication with food or milk if stomach upset occurs. It is crucial to keep the medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center contacted at 1-800-222-1222. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Dg Health Ibuprofen, 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 Dg Health Ibuprofen, 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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Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

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.