ADD CONDITION

items per page

Basic Care Ibuprofen

Last content change checked dailysee data sync status

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 2021
Label revision date
March 11, 2024
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 2021
Label revision date
March 11, 2024
Manufacturer
Amazon. com Services LLC
Registration number
ANDA077349
NDC root
72288-517

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

Ibuprofen Tablets 200 mg are a type of medication known as a nonsteroidal anti-inflammatory drug (NSAID), which is commonly used to relieve pain and reduce fever. You can take ibuprofen to temporarily alleviate minor aches and pains caused by headaches, muscular aches, arthritis, toothaches, backaches, the common cold, and menstrual cramps.

In addition to pain relief, ibuprofen is effective in lowering fever. This makes it a versatile option for managing discomfort and helping you feel better when you're unwell.

Uses

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

This medication is designed to provide you with quick relief from discomfort, making it easier to go about your daily activities. Always remember to follow the recommended guidelines for use to ensure safety and effectiveness.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you can take 1 caplet every 4 to 6 hours as needed while you have symptoms. If you find that 1 caplet isn’t enough to relieve your pain or fever, you may take 2 caplets instead. However, it’s important not to exceed 6 caplets in a 24-hour period unless your doctor advises you otherwise.

For children under 12 years old, it’s best to consult a doctor before giving any medication. This ensures that the treatment is safe and appropriate for their age and condition. Always follow your healthcare provider's instructions for the best results.

What to Avoid

You should avoid using this medication if you have ever had an allergic reaction to ibuprofen or any other pain reliever or fever reducer. Additionally, it is important not to use this medication right before or after heart surgery, as it may pose risks in these situations. Always consult with your healthcare provider if you have any concerns or questions about your health and medication use.

Side Effects

Ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. Symptoms of such reactions may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Additionally, this medication carries a risk of severe stomach bleeding, especially for those over 60, individuals with a history of stomach ulcers or bleeding, and those taking blood thinners or other NSAIDs. The risk of heart attack and stroke is also increased with NSAID use, particularly if taken in higher doses or for extended periods.

You should stop using ibuprofen and consult a doctor if you experience signs of stomach bleeding, such as feeling faint, vomiting blood, or having bloody or black stools. Seek medical attention if you notice symptoms of heart problems or stroke, like chest pain 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 if you are 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, asthma (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 are over 60, have a history of stomach ulcers or bleeding, take blood thinners or steroids, consume three or more alcoholic drinks daily, or use 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 bloody or black stools, stop using ibuprofen and contact your doctor. Seek medical attention if you experience chest pain, trouble breathing, weakness on one side of your body, slurred speech, or leg swelling. Also, consult your doctor if your pain worsens or lasts more than 10 days, your fever persists for more than 3 days, or if you notice any new symptoms. In case of an overdose, get emergency 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 or contact a Poison Control Center at 1-800-222-1222. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

Do not wait for symptoms to worsen; getting prompt assistance can be vital. Always keep emergency contact information handy and be aware of the signs of overdose to ensure your safety and the safety of those around you.

Pregnancy 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 lead to potential issues for your unborn child or complications during delivery. Always seek guidance from your doctor to ensure the safety of both you and your baby.

Lactation Use

If you are pregnant or breastfeeding, it's important to consult with a healthcare professional before using 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 children aged 12 and older, they can use it as directed for adults. The recommended dosage is one caplet every 4 to 6 hours as needed for symptoms. If one caplet doesn’t relieve pain or fever, you may give two caplets, but be sure not to exceed six caplets in a 24-hour period unless a doctor advises otherwise.

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.

Geriatric Use

As you age, it's important to be aware of certain risks associated with medications, especially nonsteroidal anti-inflammatory drugs (NSAIDs), which are commonly used for pain relief. If you are 60 years or older, you have a higher chance of experiencing severe stomach bleeding when taking these medications. Additionally, NSAIDs (excluding aspirin) can increase the risk of serious heart issues, such as heart attacks, heart failure, and strokes. This risk becomes greater if you take more than the recommended dose or use them for an extended period.

To ensure your safety, always follow the dosage instructions provided by your healthcare provider and discuss any concerns you may have about pain management options. Being informed can help you make better choices for your health.

Renal Impairment

If you have kidney problems, it's important to consult your doctor before using this medication. Your healthcare provider will want to know about any other conditions you may have, such as high blood pressure, heart disease, liver cirrhosis, asthma, or a history of stroke. This information helps ensure that the treatment is safe and appropriate for you. Always prioritize open communication with your doctor regarding your health status and any medications you are considering.

Hepatic Impairment

If you have liver problems, such as liver cirrhosis (severe scarring of the liver), it's important to be cautious with certain medications. Your healthcare provider may need to adjust your dosage or closely monitor your treatment to ensure it's safe for you. This is especially true if you also have other conditions like high blood pressure, heart disease, kidney disease, asthma, or a history of stroke.

Always communicate openly with your doctor about your liver health and any other medical issues you have. They will guide you on the best approach to manage your medications safely.

Drug Interactions

It's important to be aware that ibuprofen can interact with certain medications, particularly blood thinners (anticoagulants) and steroids. If you are taking these types of medications, you should discuss this with your healthcare provider to ensure your safety. Additionally, if you are using aspirin for heart attack or stroke prevention, ibuprofen may reduce its effectiveness, which is crucial to consider.

Moreover, combining ibuprofen with other nonsteroidal anti-inflammatory drugs (NSAIDs) like aspirin or naproxen can increase the risk of side effects. Always talk to your healthcare provider about all the medications you are taking, including over-the-counter drugs, to avoid any harmful interactions and to ensure you are receiving the best care possible.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20-25°C (68-77°F). It's important to keep it away from high humidity and avoid exposing it to excessive heat, which can be anything above 40°C (104°F).

Before using the product, check the end panel for the lot number and expiration date to ensure it is still safe and effective. Proper storage and handling will help maintain the quality and safety of the device.

Additional Information

You should take this medication orally, with the recommended dose being 1 caplet every 4 to 6 hours as needed for symptoms. If your pain or fever does not improve with 1 caplet, you may take 2 caplets instead. However, do not exceed 6 caplets in a 24-hour period unless your doctor advises otherwise.

If you are pregnant or breastfeeding, it's important to consult a healthcare professional before using this medication, especially after 20 weeks of pregnancy, as it may pose risks to your unborn child or lead to complications during delivery. Always keep this medication out of reach of children, and in case of an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

FAQ

What is Ibuprofen Tablets 200 mg used for?

Ibuprofen Tablets 200 mg are used as a pain reliever and fever reducer. They temporarily relieve minor aches and pains from headaches, muscular aches, arthritis, toothaches, backaches, the common cold, and menstrual cramps.

How should I take Ibuprofen Tablets?

Adults and children 12 years and older should take 1 caplet every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 caplet, you may take 2 caplets, but do not exceed 6 caplets 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. You should stop use and seek medical help if you experience symptoms like chest pain, trouble breathing, or signs of stomach bleeding.

Can I use Ibuprofen if I am pregnant or breastfeeding?

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

What should I do if I experience an allergic reaction to Ibuprofen?

If you experience symptoms of a severe allergic reaction, such as hives, facial swelling, or difficulty breathing, stop using ibuprofen and seek medical help immediately.

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.

Who should not use Ibuprofen?

Do not use ibuprofen if you have ever had an allergic reaction to it or any other pain reliever/fever reducer, or if you are about to have heart surgery.

How should I store Ibuprofen Tablets?

Store ibuprofen between 20-25°C (68-77°F) and avoid high humidity and excessive heat above 40°C (104°F).

Packaging Info

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

Packaging configurations for Basic Care Ibuprofen.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Ibuprofen Tablets are formulated as 200 mg coated caplets, designed for oral administration. These capsule-shaped tablets serve as a nonsteroidal anti-inflammatory drug (NSAID), functioning primarily as a pain reliever and fever reducer. Each bottle contains 100 coated caplets, ensuring a convenient supply for therapeutic use.

Uses and Indications

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

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

Dosage and Administration

Adults and children 12 years and older are advised to take 1 caplet every 4 to 6 hours as needed while symptoms persist. In cases where pain or fever does not adequately respond to 1 caplet, a dosage of 2 caplets may be administered. It is imperative that the total daily dosage does not exceed 6 caplets within a 24-hour period, unless otherwise directed by a healthcare professional.

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

Contraindications

Use of this product is contraindicated in patients with a history of allergic reactions to ibuprofen or any other pain reliever or fever reducer. Additionally, it should not be administered immediately before or after heart surgery due to potential complications associated with surgical recovery.

Warnings and Precautions

Ibuprofen may cause severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of an allergic reaction may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. In the event of an allergic reaction, it is imperative to discontinue use immediately and seek medical assistance.

The use of ibuprofen, an NSAID, carries a significant risk of severe stomach bleeding. This risk is heightened in patients who are 60 years of age or older, 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), consume three or more alcoholic beverages daily while using this product, or exceed the recommended dosage or duration of use.

Additionally, NSAIDs, excluding aspirin, are associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. The likelihood of these serious cardiovascular events is elevated when the medication is used in excess of the recommended dosage or for prolonged periods.

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 (1-800-222-1222).

Patients should be instructed to discontinue use and consult a physician if they experience any of the following symptoms indicative of stomach bleeding: feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Additionally, symptoms suggestive of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, 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.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product, which contains an NSAID. 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.

Additionally, the use of this NSAID carries a warning for potential severe stomach bleeding, with an increased risk in patients aged 60 or older, those with a history of stomach ulcers or bleeding problems, individuals taking blood thinners or steroid medications, and those consuming three or more alcoholic drinks daily while using this product. Symptoms indicative of stomach bleeding include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain.

The risk of heart attack, heart failure, and stroke is also heightened with the use of NSAIDs, excluding aspirin. This risk escalates with prolonged use or exceeding the recommended dosage. Patients should be vigilant for symptoms of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling.

Common adverse reactions may include gastrointestinal discomfort, and patients are advised to discontinue use and consult a healthcare provider if pain worsens or persists beyond 10 days, fever intensifies or lasts more than three days, redness or swelling occurs in the painful area, or any new symptoms arise.

Patients with a history of serious side effects from pain relievers or fever reducers, those with pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke, should seek medical advice before using this product. Furthermore, individuals taking aspirin for cardiovascular protection should consult a healthcare professional, as ibuprofen may diminish the cardioprotective effects of aspirin.

Drug Interactions

Ibuprofen has several notable interactions with other medications, particularly within the classes of anticoagulants and nonsteroidal anti-inflammatory drugs (NSAIDs).

Anticoagulants and Steroids Ibuprofen may interact with blood-thinning medications (anticoagulants) and steroid drugs. This interaction could potentially enhance the risk of bleeding. It is advisable to monitor patients closely for signs of bleeding and consider dosage adjustments of the anticoagulant or steroid as necessary.

Aspirin When ibuprofen is taken concurrently with aspirin, it may diminish the cardioprotective effects of aspirin, particularly when aspirin is used for the prevention of heart attack or stroke. Patients should be advised to consult their healthcare provider regarding the timing and dosing of these medications to optimize therapeutic outcomes.

Other NSAIDs The concomitant use of ibuprofen with other NSAIDs, whether prescription or nonprescription (such as aspirin or naproxen), may increase the risk of adverse effects. It is recommended that healthcare providers assess the necessity of using multiple NSAIDs and consider alternative pain management strategies to minimize potential risks.

Packaging & NDC

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

Packaging configurations for Basic Care Ibuprofen.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For children aged 12 years and older, the medication can be administered as directed for adults.

The recommended dosing for pediatric patients is 1 caplet every 4 to 6 hours while symptoms persist. If pain or fever does not adequately respond to 1 caplet, 2 caplets may be taken. It is important not to exceed 6 caplets in a 24-hour period unless otherwise directed by a healthcare provider.

Parents and caregivers should ensure that the medication is kept out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222.

Geriatric Use

Elderly patients, particularly those aged 60 and older, may experience an increased risk of severe stomach bleeding when using this medication. It is essential for healthcare providers to monitor these patients closely for any signs of gastrointestinal complications.

Additionally, the use of nonsteroidal anti-inflammatory drugs (NSAIDs), excluding aspirin, is associated with an elevated risk of cardiovascular events, including heart attack, heart failure, and stroke. This risk is further heightened in elderly patients who exceed the recommended dosage or duration of treatment. Therefore, careful consideration of dosage adjustments and ongoing assessment of the patient's cardiovascular status is advised when prescribing this medication to geriatric patients.

Pregnancy

Pregnant patients should consult a healthcare professional before using this medication, particularly if they are in the later stages of pregnancy or breastfeeding. It is crucial 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 healthcare professional before using this medication. 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 available regarding the excretion of ibuprofen in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering the use of this medication 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, asthma, or a history of stroke, as these factors may influence the management of their renal function and the appropriateness of treatment. Monitoring and potential dosing adjustments may be necessary based on the patient's renal status to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment may experience altered pharmacokinetics of the medication. It is essential to assess liver function prior to initiating treatment and to monitor liver function periodically during therapy.

In patients with liver cirrhosis, dosage adjustments may be necessary to mitigate the risk of adverse effects due to impaired drug metabolism. The prescribing physician should evaluate the severity of hepatic impairment and consider potential restrictions on the use of this medication in such patients.

Close monitoring of liver function tests is recommended, particularly in those with significant liver disease, to ensure safe and effective 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. Healthcare professionals are advised to call the Poison Control Center at 1-800-222-1222 for guidance on managing the situation effectively.

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 as they arise.

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 to address any complications that may develop as a result of the overdose.

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 or additional nonclinical toxicology details are available in the provided data. Furthermore, there are no specific findings related to 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 routine pharmacovigilance activities.

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 that patients take the medication with food or milk if they experience stomach upset.

Providers should encourage patients to consult with a doctor before using the medication if they have experienced problems or serious side effects from pain relievers or fever reducers in the past. Additionally, patients should be informed to ask a doctor before use if they have a history of stomach issues, such as heartburn, or if the stomach bleeding warning applies to them.

Patients with high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke should also be advised to consult a doctor prior to use. Furthermore, it is important for patients taking a diuretic to seek medical advice before using the medication.

Healthcare providers should inform patients that if they are taking aspirin for heart attack or stroke, they should consult a doctor or pharmacist, as ibuprofen may reduce the effectiveness of aspirin in this context. Lastly, patients under a doctor's care for any serious condition or those taking any other medications should be encouraged to discuss their use of this medication with their healthcare provider or pharmacist.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for reference. It is essential to store the product at a temperature range of 20-25°C (68-77°F). Care should be taken to avoid exposure to high humidity and excessive heat, particularly temperatures exceeding 40°C (104°F). For tracking purposes, the lot number and expiration date can be found on the end panel of the packaging.

Additional Clinical Information

Patients should take the medication orally, with a recommended dosage of one caplet every 4 to 6 hours while symptoms persist. If pain or fever does not adequately respond to one caplet, two caplets may be taken. However, patients must not exceed six caplets in a 24-hour period unless directed by a healthcare professional.

Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional before use. It is particularly crucial to avoid ibuprofen after 20 weeks of pregnancy unless specifically instructed by a doctor, as it may pose risks to the unborn child or lead to complications during delivery. Additionally, patients should keep the medication out of reach of children and seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222) in the event of an overdose.

Drug Information (PDF)

This file contains official product information for Basic Care 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 Basic Care 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.

Learn more in our Editorial Policy

Last AI update:

Primary FDA sources:

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.