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Ibuprofen

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Active ingredient
Ibuprofen 200 mg
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Tablet, Film Coated
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 1988
Label revision date
May 5, 2025
Active ingredient
Ibuprofen 200 mg
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Tablet, Film Coated
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 1988
Label revision date
May 5, 2025
Manufacturer
H E B
Registration number
ANDA075010
NDC root
37808-921

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Drug Overview

Ibuprofen is a type of medication known as a nonsteroidal anti-inflammatory drug (NSAID) that comes in 200 mg tablets. It is commonly used to temporarily relieve minor aches and pains, including those caused by menstrual cramps, toothaches, headaches, backaches, muscular aches, and minor arthritis pain. Additionally, ibuprofen can help reduce fever, making it a versatile option for managing discomfort and illness.

This medication works by blocking certain substances in the body that cause inflammation and pain, providing you with relief when you need it most. If you're looking for a way to ease your discomfort or lower a fever, ibuprofen may be a suitable choice.

Uses

You can use this medication to temporarily relieve minor aches and pains from various conditions, including menstrual cramps, toothaches, the common cold, backaches, headaches, muscular aches, and minor arthritis pain. Additionally, it can help reduce fever for a short period.

This medication is designed to provide you with comfort when you're experiencing these common discomforts, allowing you to feel better and get back to your daily activities.

Dosage and Administration

It's important to follow the dosage instructions carefully to ensure your safety and effectiveness of the medication. You should never take more than the directed amount, and it's best to use the smallest effective dose. For adults and children aged 12 years and older, the recommended dosage is to take 1 tablet every 4 to 6 hours as needed while symptoms persist. If you find that 1 tablet isn't enough to relieve your pain or fever, you can take 2 tablets. However, make sure not to exceed 6 tablets in a 24-hour period unless your doctor advises otherwise.

If you have a child under 12 years old, it's essential to consult a doctor before giving them this medication. Always prioritize safety and follow these guidelines to manage your symptoms effectively.

What to Avoid

You should avoid using this medication if you have ever had an allergic reaction to any other pain reliever or fever reducer. Additionally, it is important not to use it right before or after heart surgery, as this could pose serious health risks. Always consult with your healthcare provider if you have any concerns or questions about your medical history and the use of this medication. Your safety is the top priority.

Side Effects

Ibuprofen can cause serious side effects, including severe allergic reactions, particularly in individuals allergic to aspirin. Symptoms of an allergic reaction may include skin reddening, wheezing (asthma), rash, facial swelling, shock, blisters, and hives. Additionally, this medication can lead to severe stomach bleeding, especially if you take it for longer than recommended, are over 60 years old, or consume alcohol regularly. There is also an increased risk of heart attack and stroke associated with NSAIDs like ibuprofen, particularly if used in higher doses or for extended periods.

If you experience symptoms such as faintness, bloody or black stools, vomiting blood, or persistent stomach pain, you should stop using ibuprofen and consult a doctor. Other warning signs include chest pain, slurred speech, leg swelling, difficulty breathing, or weakness on one side of the body. It's important to talk to your doctor before using ibuprofen if you have a history of stomach issues, high blood pressure, heart disease, or are taking other medications, especially aspirin.

Warnings and Precautions

Ibuprofen can cause serious allergic reactions, especially if you are allergic to aspirin. Symptoms may include skin reddening, wheezing, rash, facial swelling, shock, blisters, or hives. 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 take it for longer than recommended, are over 60 years old, or consume alcohol regularly. Additionally, using ibuprofen increases the risk of heart attack and stroke, especially if taken in higher doses or for extended periods. If you notice signs of stomach bleeding, such as feeling faint, having bloody or black stools, or vomiting blood, stop using ibuprofen and contact your doctor. You should also seek medical attention if you experience chest pain, slurred speech, leg swelling, trouble breathing, or weakness on one side of your body. Always consult your doctor if your pain worsens or lasts more than 10 days, or if you have a fever that persists for more than 3 days.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately or contact a Poison Control Center. Signs of an overdose can vary, but they may include unusual symptoms that are more severe than what you would typically experience with the medication.

Don’t wait for symptoms to worsen; getting prompt assistance can be vital. Always keep emergency contact information handy, and remember that acting quickly can make a significant difference in your safety.

Pregnancy Use

If you are pregnant or breastfeeding, it’s crucial to consult with a healthcare professional before using any medication, including ibuprofen. This is particularly important if you are 20 weeks pregnant or later, as using ibuprofen during this time can lead to potential issues for your unborn child or complications during delivery. Always prioritize your health and the health of your baby by seeking guidance from your doctor.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication, including ibuprofen. This is particularly crucial if you are 20 weeks pregnant or later, as using ibuprofen during this time can potentially lead to issues for your unborn child or complications during delivery. Always prioritize your health and the health of your baby by seeking guidance from your doctor.

Pediatric Use

If your child is under 12 years old, it's important to consult a doctor before giving them this medication. For those aged 12 and older, you can administer 1 tablet every 4 to 6 hours as needed for symptoms. If one tablet isn't enough to relieve pain or fever, you may give 2 tablets, but be sure not to exceed 6 tablets in a 24-hour period unless a doctor advises otherwise. Always follow these guidelines to ensure your child's safety and well-being.

Geriatric Use

As you age, it's important to be aware of certain health risks associated with medications. If you are 60 years or older, there is a higher chance of experiencing severe stomach bleeding. This risk increases with the use of certain medications, so it's crucial to follow your healthcare provider's instructions carefully.

Additionally, older adults may face a greater risk of heart attack, heart failure, and stroke, especially if medications are taken in higher doses or for longer periods than recommended. Always discuss your medication plan with your doctor to ensure it is safe and appropriate for your age and health status.

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), asthma, or have experienced a stroke. Your healthcare provider can help determine if this medication is safe for you and whether any adjustments are needed based on your kidney function. Always prioritize open communication with your doctor regarding your health conditions.

Hepatic Impairment

If you have liver problems, such as liver cirrhosis (a severe scarring of the liver), 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, kidney disease, asthma, or a history of stroke. Always prioritize open communication with your doctor to ensure safe and effective treatment.

Drug Interactions

It's important to talk to your healthcare provider about any medications you are taking, including over-the-counter options like ibuprofen. For instance, if you are using aspirin to prevent heart attacks or strokes, taking ibuprofen may reduce its effectiveness. Additionally, if you are on blood thinners (anticoagulants) or steroids, combining these with ibuprofen can increase your risk of stomach bleeding.

Using nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen can also raise your chances of experiencing serious heart issues, such as heart attack or stroke, especially if you take them for longer than recommended. Always consult with your healthcare provider to ensure your medications are safe and effective for your health needs.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20º-25ºC (68º-77ºF). It's important to avoid exposing it to excessive heat, which can reach up to 40ºC (104ºF), as this may compromise its effectiveness. Always check the expiration date on the package and use the product before that date to ensure safety and reliability.

When handling the product, make sure to maintain a clean environment to prevent contamination. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should take this medication orally. If you are pregnant or breastfeeding, it's important to consult a healthcare professional before using it. Specifically, avoid using ibuprofen after 20 weeks of pregnancy unless your doctor has specifically instructed you to do so, as it may pose risks to your unborn child or lead to complications during delivery.

FAQ

What is Ibuprofen?

Ibuprofen is a pain reliever and fever reducer classified as a nonsteroidal anti-inflammatory drug (NSAID). It is available in 200 mg tablets.

What conditions does Ibuprofen temporarily relieve?

Ibuprofen temporarily relieves minor aches and pains due to menstrual cramps, toothache, the common cold, backache, headache, muscular aches, and minor pain of arthritis.

How should I take Ibuprofen?

Adults and children 12 years and over should take 1 tablet every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 tablet, you may take 2 tablets, but do not exceed 6 tablets in 24 hours unless directed by a doctor.

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 you experience symptoms like chest pain or bloody stools.

Can I take Ibuprofen if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before use. It is especially important not to use Ibuprofen at 20 weeks or later in pregnancy unless directed by a doctor.

What should I do if I experience signs of stomach bleeding?

Stop using Ibuprofen and seek medical help if you experience symptoms like feeling faint, bloody or black stools, or vomit blood.

What should I avoid while taking Ibuprofen?

Do not take more than directed, and avoid using it right before or after heart surgery. Also, be cautious if you are taking blood thinners or have a history of stomach problems.

How should I store Ibuprofen?

Store Ibuprofen between 20º-25ºC (68º-77ºF) and avoid excessive heat above 40ºC (104ºF).

Packaging Info

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

Packaging configurations for Ibuprofen.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Ibuprofen Tablets USP contain 200 mg of ibuprofen per tablet and are classified as a nonsteroidal anti-inflammatory drug (NSAID) indicated for the relief of pain and reduction of fever. The product is packaged in a bottle containing 500 coated tablets. Each bottle is equipped with a tamper-evident safety seal; the product should not be used if the seal under the cap is broken or missing. This formulation is not manufactured or distributed by PF Consumer Healthcare 1 LLC, the owner of the registered trademark Advil® Tablets.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including menstrual cramps, toothache, the common cold, backache, headache, muscular aches, and minor pain of arthritis. Additionally, it is indicated for the temporary reduction of fever.

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

Dosage and Administration

Patients should adhere strictly to the recommended dosage and not exceed the directed amount. The smallest effective dose should be utilized to manage symptoms effectively.

For adults and children aged 12 years and older, the recommended dosage is 1 tablet every 4 to 6 hours as needed while symptoms persist. If pain or fever does not adequately respond to 1 tablet, a maximum of 2 tablets may be taken. However, the total dosage must not exceed 6 tablets within a 24-hour period unless otherwise directed by a healthcare professional.

For children under 12 years of age, it is advised to consult a doctor for appropriate dosing recommendations.

Contraindications

Use is contraindicated in patients with a history of allergic reactions to any pain reliever or fever reducer. Additionally, administration is contraindicated immediately before or after heart surgery due to potential complications associated with surgical recovery.

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 skin reddening, asthma (wheezing), rash, facial swelling, shock, blisters, and hives. 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 experiencing this adverse effect is heightened under certain conditions, including prolonged use beyond the recommended duration, concurrent use of anticoagulants or steroid medications, being aged 60 years or older, taking other NSAIDs (whether prescription or over-the-counter, such as aspirin, ibuprofen, or naproxen), having a history of stomach ulcers or bleeding disorders, or consuming three or more alcoholic beverages daily while using this product.

Furthermore, NSAIDs, excluding aspirin, are linked to an increased risk of heart attack, heart failure, and stroke, which can be fatal. The risk escalates with the use of higher doses or extended duration beyond the recommended guidelines.

In cases of overdose, immediate medical attention is required. Healthcare professionals should advise patients to contact a Poison Control Center or seek emergency medical help without delay.

Patients should be instructed to discontinue use and consult a physician if they experience any signs of stomach bleeding, which may manifest as feeling faint, having bloody or black stools, vomiting blood, or experiencing persistent stomach pain. Additionally, symptoms suggestive of heart problems or stroke, such as chest pain, slurred speech, leg swelling, difficulty breathing, or weakness on one side of the body, warrant immediate medical evaluation.

Patients should also seek medical advice if pain worsens or persists beyond 10 days, if fever intensifies or lasts more than 3 days, if redness or swelling occurs in the affected area, or if any new symptoms arise. Regular monitoring and assessment of these parameters are essential for the safe use of ibuprofen.

Side Effects

Patients using ibuprofen may experience a range of adverse reactions, which can be categorized by seriousness and frequency.

Severe allergic reactions have been reported, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions may include skin reddening, asthma (wheezing), rash, facial swelling, shock, blisters, and hives.

The use of ibuprofen, as a nonsteroidal anti-inflammatory drug (NSAID), carries a significant risk of severe stomach bleeding. This risk is heightened in patients who take higher doses or use the medication for extended periods, those who are 60 years of age or older, individuals taking anticoagulants or steroid medications, and patients with a history of stomach ulcers or bleeding problems. Additionally, consuming three or more alcoholic drinks daily while using ibuprofen increases the likelihood of gastrointestinal complications.

Patients should be aware that NSAIDs, excluding aspirin, are associated with an increased 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 longer than directed.

Participants in clinical trials and postmarketing experiences have indicated that patients should discontinue use and consult a healthcare provider if they experience signs of stomach bleeding, such as feeling faint, having bloody or black stools, vomiting blood, or experiencing persistent stomach pain. Symptoms indicative of heart problems or stroke, including chest pain, slurred speech, leg swelling, difficulty breathing, or weakness on one side of the body, also warrant immediate medical attention. Furthermore, patients should seek medical advice if pain worsens or persists beyond 10 days, if fever intensifies or lasts more than three days, if redness or swelling occurs in the painful area, or if any new symptoms arise.

Before using ibuprofen, patients with a history of stomach issues, such as heartburn, or those taking diuretics, should consult a healthcare professional. Individuals with high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke should also seek medical advice prior to use. It is important to note that ibuprofen may diminish the cardioprotective effects of aspirin in patients taking it for heart attack or stroke prevention.

Drug Interactions

Ibuprofen may interact with several classes of medications, leading to significant clinical effects that warrant careful consideration.

Interactions with Antiplatelet Agents:Ibuprofen has the potential to diminish the cardioprotective effects of aspirin when both medications are taken concurrently for the prevention of heart attack or stroke. It is advisable to avoid the simultaneous use of ibuprofen and aspirin for these indications to ensure optimal therapeutic outcomes.

Interactions with Anticoagulants and Corticosteroids:The concomitant use of ibuprofen with anticoagulants or corticosteroids increases the risk of gastrointestinal bleeding. Clinicians should monitor patients closely for signs of bleeding and consider dosage adjustments or alternative therapies when prescribing ibuprofen in patients receiving these medications.

Cardiovascular Risks:The use of nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen, is associated with an elevated risk of cardiovascular events such as heart attack, heart failure, and stroke. This risk is particularly pronounced when ibuprofen is used in higher doses or for extended periods. It is recommended that healthcare providers assess the necessity of ibuprofen therapy and consider the lowest effective dose for the shortest duration possible in patients with cardiovascular risk factors.

Packaging & NDC

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

Packaging configurations for Ibuprofen.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents aged 12 years and older, the recommended dosage is 1 tablet every 4 to 6 hours as needed for symptom relief. If pain or fever does not adequately respond to 1 tablet, 2 tablets may be administered. The maximum dosage should not exceed 6 tablets in a 24-hour period unless otherwise directed by a healthcare provider.

Geriatric Use

Elderly patients may have an increased risk of severe stomach bleeding, particularly those aged 60 years and older. It is essential for healthcare providers to monitor these patients closely for any signs of gastrointestinal bleeding, especially when prescribing medications that may exacerbate this risk.

Additionally, the risk of heart attack, heart failure, and stroke is elevated in geriatric patients who use the medication in excess of the recommended dosage or for an extended duration. Therefore, careful consideration of dosage and treatment duration is crucial in this population to mitigate these potential cardiovascular risks. Regular assessment and monitoring of elderly patients are advised to ensure their safety while on treatment.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. It is particularly important to avoid the use of ibuprofen after 20 weeks of gestation unless specifically directed by a physician, as it may pose risks to the developing fetus and lead to complications during delivery. Healthcare providers should carefully evaluate the potential benefits and risks when considering the use of this medication in pregnant patients.

Lactation

Lactating mothers are advised to consult a health professional before using this medication while breastfeeding. It is particularly important to avoid the use of ibuprofen at 20 weeks of gestation or later unless specifically directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery. There is no specific data provided regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, healthcare providers should weigh the potential benefits against the risks when considering this medication for lactating mothers.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have underlying conditions such as high blood pressure, heart disease, liver cirrhosis, or asthma. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the severity of kidney disease. Caution is advised in patients with reduced kidney function to ensure safe and effective use of the medication.

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 for these patients to discuss their liver function status, as compromised liver function may influence the safety and efficacy of the treatment. Monitoring of liver function may be warranted in this population to ensure appropriate management and to mitigate potential risks associated with the use of the medication.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be vigilant in monitoring for symptoms that may arise from an overdose. While specific symptoms are not detailed in the provided information, it is essential to be aware that they can vary based on the substance involved and the individual’s health status.

Management of an overdose typically involves supportive care and symptomatic treatment. The healthcare provider should assess the patient's condition and implement appropriate measures based on the severity of the overdose and the symptoms presented. Continuous monitoring and evaluation are recommended to ensure patient safety and effective management of the situation.

Nonclinical Toxicology

It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor, as it may cause problems in the unborn child or complications during delivery. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no details provided regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of ibuprofen. Reports have included gastrointestinal bleeding, renal impairment, and elevations in liver enzymes. Serious skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have also been documented. Additionally, cases of cardiovascular events, including heart attack and stroke, have been reported. Some patients have experienced allergic reactions, which include anaphylaxis and angioedema. Furthermore, elevated blood pressure has been noted in certain patients using ibuprofen, along with instances of gastrointestinal perforation.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is important to inform patients that they should not use this medication if they have a history of allergic reactions to any other pain reliever or fever reducer. Additionally, patients should be cautioned against using this product right before or after heart surgery.

Patients should be instructed to stop using the medication and consult a doctor if they experience any signs of stomach bleeding, which may include feeling faint, having bloody or black stools, vomiting blood, or experiencing stomach pain that does not improve. They should also be made aware of the symptoms of heart problems or stroke, such as chest pain, slurred speech, leg swelling, trouble breathing, or weakness in one part or side of the body, and advised to seek medical attention if these occur.

Healthcare providers should emphasize that patients must stop using the medication and consult a doctor if their pain worsens or persists for more than 10 days, if their fever worsens or lasts more than 3 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 they experience stomach upset. It is also essential to recommend that patients consult a doctor before use if they have a history of stomach problems, such as heartburn, or if they are taking a diuretic. Patients with high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke should also be encouraged to seek medical advice prior to use.

Furthermore, patients should be informed to consult a doctor before use if the stomach bleeding warning applies to them, if they have experienced problems or serious side effects from taking pain relievers or fever reducers, or if they are under a doctor's care for any serious condition. It is crucial to advise patients to speak with a doctor or pharmacist before using this medication if they are taking aspirin for heart attack or stroke, as ibuprofen may diminish the benefits of aspirin. Lastly, patients should be encouraged to consult a doctor or pharmacist before use if they are taking any other medications.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a controlled room temperature between 20ºC and 25ºC (68ºF to 77ºF). Care should be taken to avoid exposure to excessive heat, defined as temperatures exceeding 40ºC (104ºF). It is essential to adhere to the expiration date indicated on the package to ensure product efficacy and safety.

Additional Clinical Information

The route of administration for the medication is oral. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is particularly crucial to avoid ibuprofen after 20 weeks of pregnancy unless specifically directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery.

Drug Information (PDF)

This file contains official product information for 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 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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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.