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Easy Care First Aid Ibuprofen

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This product has been discontinued

Active ingredient
Ibuprofen 200 mg
Other brand names
Dosage form
Tablet, Coated
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2017
Label revision date
October 3, 2019
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 200 mg
Other brand names
Dosage form
Tablet, Coated
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2017
Label revision date
October 3, 2019
Manufacturer
Tender Corporation
Registration number
ANDA079174
NDC root
44224-0018
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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

Easy Care First Aid Ibuprofen is a medication that comes in the form of two tablets. It is designed to temporarily relieve minor aches and pains, which can include headaches, toothaches, backaches, menstrual cramps, muscular aches, and pain associated with the common cold or minor arthritis. Additionally, it helps to temporarily reduce fever, making it a versatile option for managing discomfort and fever symptoms.

Uses

You can use this medication to temporarily relieve minor aches and pains from various conditions, including headaches, toothaches, backaches, menstrual cramps, muscular aches, and even pain associated with the common cold or minor arthritis. Additionally, it can help reduce fever, providing you with some comfort when you're not feeling well.

Rest assured, there are no teratogenic effects (which means it doesn't cause birth defects) associated with this medication, making it a safer option for those who may be concerned about such risks.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you can take 1 tablet every 4 to 6 hours as needed while you have symptoms. If your pain or fever doesn’t improve with just 1 tablet, you may take 2 tablets instead. However, it’s important not to exceed 6 tablets in a 24-hour period unless your doctor advises otherwise.

For children under 12 years of age, this medication is not recommended, so please do not give it to them. Always follow the guidance of a healthcare professional for the best results and safety.

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, or if you are about to undergo or have just had heart surgery. It's important to be aware of potential serious side effects. If you notice any signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain, stop using the medication and consult your doctor immediately.

Additionally, seek medical attention if you experience symptoms of heart problems or stroke, including chest pain, difficulty breathing, weakness on one side of your body, slurred speech, or swelling in your legs. You should also stop using the medication if your pain worsens or lasts longer than 10 days, if your fever intensifies or lasts more than 3 days, if you see redness or swelling in the painful area, or if you develop any new or unexpected symptoms.

Side Effects

You should be aware of several important side effects and warnings associated with this medication. If you experience signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain, seek medical attention immediately. Additionally, watch for symptoms of heart problems or stroke, including chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or swelling in your legs. If your pain worsens or lasts more than 10 days, or if a fever persists for more than 3 days, contact your healthcare provider.

It's also crucial to be cautious if you have a history of stomach issues, high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or if you are taking certain medications like diuretics or aspirin for heart conditions, as this medication may interact with them. Always inform your doctor about any new or unexpected symptoms you experience while taking this medication.

Warnings and Precautions

If you ever take too much of this medication, it's crucial to seek medical help immediately or contact a Poison Control Center. You should avoid using this medication if you have a history of allergic reactions to pain relievers or fever reducers, and it’s not safe to use right before or after heart surgery.

While there are no specific lab tests required for monitoring, you should be vigilant for signs that indicate you need to stop taking the medication and call your doctor. These signs include feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that doesn’t improve. Additionally, if you notice symptoms of heart problems or stroke—such as chest pain, difficulty breathing, weakness on one side of your body, slurred speech, or swelling in your legs—seek medical attention right away. If your pain worsens or lasts more than 10 days, or if your fever persists for more than 3 days, it’s important to consult your doctor. Always be alert for any new or unexpected symptoms as well.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While the specific signs of an overdose are not detailed, common symptoms can include extreme drowsiness, confusion, or difficulty breathing. If you notice any of these signs, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's crucial to provide them with as much information as possible about the substance taken and the amount, if known. Remember, acting quickly can make a significant difference in your safety and health.

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 crucial to ensure the safety of both you and your baby.

Particularly during the last three months of pregnancy, you should avoid using ibuprofen unless your doctor specifically advises you to do so. Using ibuprofen at this stage can lead to potential issues for your unborn child or complications during delivery. Always prioritize open communication with your healthcare provider regarding any medications you may consider.

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 during the last three months of pregnancy, as using ibuprofen at this stage can lead to potential issues for your unborn child or complications during delivery. Always prioritize your health and your baby's well-being by seeking guidance from your doctor.

Pediatric Use

It’s important to be cautious when giving medication to children. You should not give this medication to children under 12 years of age. For those aged 12 and older, the recommended dosage is 1 tablet every 4 to 6 hours as needed for symptoms. If one tablet isn’t enough to relieve pain or fever, you can give 2 tablets, but be sure not to exceed 6 tablets in a 24-hour period unless a doctor advises otherwise. Always consult with a healthcare professional if you have any questions or concerns about dosing for your child.

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 can be further increased if you take more than the recommended dose or use the medication for a longer period than advised.

Additionally, older adults should be cautious, as using higher doses or extending the duration of use may also raise the risk of heart attack or stroke. Always follow your healthcare provider's instructions carefully to help minimize these risks and ensure your safety.

Renal Impairment

If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. Regular monitoring of your kidney function tests is essential to ensure your safety and the effectiveness of your treatment. If your creatinine clearance (a measure of how well your kidneys filter waste) is less than 30 mL/min, a reduced dose is recommended. Additionally, if you have severe renal impairment, special monitoring will be necessary to manage your health effectively. Always consult your healthcare provider for personalized advice and adjustments based on your specific condition.

Hepatic Impairment

If you have liver problems, it's important to know that your dosage of this medication may need to be adjusted. This means that your doctor might change how much of the drug you take to ensure it's safe and effective for you. Additionally, special monitoring of liver function tests (which check how well your liver is working) is recommended to keep an eye on your health.

Always exercise caution when taking this medication if you have liver dysfunction. It's essential to communicate openly with your healthcare provider about your liver condition so they can provide the best care tailored to your needs.

Drug Interactions

It's important to be aware of how certain medications can interact with each other. For instance, if you take ibuprofen, it may reduce the effectiveness of aspirin when used for preventing heart attacks or strokes. Additionally, if you are on blood thinners (medications that help prevent blood clots) or steroids, the risk of stomach bleeding can increase when taking ibuprofen.

Always discuss your medications with your healthcare provider, especially if you are using ibuprofen for an extended period or at higher doses, as this can raise the risk of heart attack or stroke. Your healthcare provider can help ensure that your treatment plan is safe and effective for your specific health needs.

Storage and Handling

To ensure the safety and effectiveness of your product, store it in a cool, dry place at a temperature between 68-77°F (20-25°C). It's important to avoid exposing it to excessive heat, particularly temperatures above 40°C (104°F), as this can compromise its quality.

When handling the product, make sure to use only tamper-evident sealed packets. If you notice any packets that are opened or torn, do not use them, as this could pose a safety risk. Following these guidelines will help you maintain the integrity of the product and ensure safe usage.

Additional Information

No further information is available.

FAQ

What is Easy Care First Aid Ibuprofen used for?

Easy Care First Aid Ibuprofen temporarily relieves minor aches and pains associated with headaches, toothaches, backaches, menstrual cramps, common colds, muscular aches, and minor arthritis pain. It also temporarily reduces fever.

What is the recommended dosage for adults and children 12 years and older?

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

Can children under 12 years take Easy Care First Aid Ibuprofen?

No, you should not give Easy Care First Aid Ibuprofen to children under 12 years of age.

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

Stop using the medication and ask a doctor if you feel faint, vomit blood, have bloody or black stools, or have stomach pain that does not get better.

What are the risks of using Easy Care First Aid Ibuprofen?

The risk of heart attack or stroke may increase if you use more than directed or for longer than directed. Additionally, there is a higher chance of severe stomach bleeding if you are age 60 or older.

Is it safe to use Easy Care First Aid Ibuprofen during pregnancy?

If you are pregnant or breastfeeding, you should ask a health professional before use. It is especially important not to use it during the last 3 months of pregnancy unless directed by a doctor.

What should I do in case of an overdose?

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

How should I store Easy Care First Aid Ibuprofen?

Store it at 68-77°F (20-25°C) and avoid excessive heat above 40°C (104°F). Ensure packets are tamper evident and do not use any opened or torn packets.

Packaging Info

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

Packaging configurations for Easy Care First Aid Ibuprofen.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Easy Care First Aid Ibuprofen contains ibuprofen as its active ingredient. The product is presented in a dosage form of two tablets. For comprehensive details regarding the product, refer to the accompanying card.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with headache, toothache, backache, menstrual cramps, common cold, muscular aches, and minor arthritis pain. 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 aged 12 years and older are advised to take 1 tablet every 4 to 6 hours as needed while symptoms persist. In cases where pain or fever does not adequately respond to 1 tablet, a dosage of 2 tablets may be administered. It is imperative that the total daily dosage does not exceed 6 tablets within a 24-hour period, unless otherwise directed by a healthcare professional.

For children under 12 years of age, this medication is contraindicated and should not be administered.

Contraindications

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

Patients should discontinue use and consult a healthcare professional if they experience signs of stomach bleeding, including feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain. Symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, also warrant immediate medical attention. Furthermore, if pain worsens or persists beyond 10 days, fever intensifies or lasts more than 3 days, redness or swelling occurs in the affected area, or any new or unexpected symptoms arise, the patient should seek medical advice.

Warnings and Precautions

In the event of an overdose, immediate medical assistance should be sought, or a Poison Control Center should be contacted without delay.

Patients should refrain from using this medication if they have a history of allergic reactions to any other pain reliever or fever reducer. Additionally, it is contraindicated for use immediately before or after undergoing heart surgery.

Healthcare professionals should advise patients to discontinue use and consult a physician if any of the following symptoms occur, as they may indicate serious conditions:

  • Signs of stomach bleeding, which include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain.

  • Symptoms suggestive of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or swelling in the legs.

  • Worsening pain that persists beyond 10 days.

  • Fever that intensifies or lasts longer than 3 days.

  • Presence of redness or swelling in the area of pain.

  • Any new or unexpected symptoms that arise.

No specific laboratory tests are recommended for monitoring during the use of this medication. However, vigilance in observing the aforementioned symptoms is essential for ensuring patient safety.

Side Effects

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

Serious adverse reactions include signs of stomach bleeding, which may manifest as feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve. Additionally, symptoms indicative of heart problems or stroke should be closely monitored. These symptoms include chest pain, difficulty breathing, weakness on one side of the body, slurred speech, and swelling in the legs. Patients should seek immediate medical attention if they experience pain that worsens or persists for more than 10 days, fever that intensifies or lasts longer than 3 days, or if there is redness or swelling in the area of pain. Any new or unexpected symptoms should also prompt a consultation with a healthcare provider.

Common adverse reactions may include problems or serious side effects associated with the use of pain relievers or fever reducers. Patients with a history of stomach issues, such as heartburn, or those with conditions like high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke should exercise caution. The use of diuretics or aspirin for heart attack or stroke is also a concern, as ibuprofen may diminish the cardioprotective effects of aspirin. Patients under a physician's care for any serious condition or those taking other medications should discuss potential interactions and risks with their healthcare provider.

It is essential for patients to be aware of these adverse reactions and to communicate any concerns or symptoms to their healthcare provider promptly.

Drug Interactions

Ibuprofen may diminish the cardioprotective effects of aspirin when used for the prevention of heart attack or stroke. It is advisable to avoid concurrent use of these medications for optimal therapeutic outcomes.

When ibuprofen is administered alongside anticoagulants or steroid medications, there is an increased risk of gastrointestinal bleeding. Clinicians should monitor patients closely for signs of bleeding and consider appropriate dosage adjustments or alternative therapies as necessary.

Additionally, exceeding the recommended dosage or duration of ibuprofen therapy may elevate the risk of cardiovascular events, such as heart attack or stroke. It is essential to adhere to prescribed guidelines to mitigate these risks.

Packaging & NDC

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

Packaging configurations for Easy Care First Aid Ibuprofen.
Details

Pediatric Use

Pediatric patients under 12 years of age should not be administered this medication. For adolescents 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, 2 tablets may be taken. The maximum allowable dosage is 6 tablets within a 24-hour period, unless otherwise directed by a healthcare professional.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk for severe stomach bleeding. This heightened risk necessitates careful consideration when prescribing medications that may contribute to gastrointestinal complications.

Additionally, the risk of heart attack or stroke may be elevated in geriatric patients who exceed the recommended dosage or duration of treatment. Therefore, it is crucial for healthcare providers to monitor elderly patients closely and to adhere strictly to dosing guidelines to mitigate these risks. Regular assessment and patient education regarding the importance of following prescribed dosages are essential components of care for this population.

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 during the last trimester of pregnancy unless specifically directed by a physician, as it may pose risks to the developing fetus and lead to complications during delivery.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. It is particularly important to avoid the use of ibuprofen during the last three months of pregnancy unless specifically directed by a doctor, 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 this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering its use in lactating mothers.

Renal Impairment

Patients with renal impairment may require dosage adjustments to ensure safety and efficacy. It is essential to monitor renal function tests regularly in patients with kidney problems to assess their condition accurately. For patients with a creatinine clearance of less than 30 mL/min, a reduced dose is recommended to mitigate the risk of adverse effects. Additionally, special monitoring is necessary for patients with severe renal impairment to ensure appropriate management of their treatment.

Hepatic Impairment

Patients with hepatic impairment may require dosage adjustments due to compromised liver function. It is essential to monitor liver function tests closely in this population to ensure safety and efficacy. Caution should be exercised when administering the drug to patients with liver dysfunction, as their altered metabolic capacity may affect drug clearance and overall treatment outcomes.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the substance involved, estimated dose, and time of ingestion, is crucial for effective management and treatment.

Nonclinical Toxicology

It is especially important not to use ibuprofen during the last three months of pregnancy unless specifically 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 regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has indicated that ibuprofen may lead to severe allergic reactions, particularly in individuals with a known allergy to aspirin. Reported symptoms of such reactions include hives, skin reddening, asthma (wheezing), facial swelling, rash, shock, and blisters.

There is a recognized risk of stomach bleeding associated with ibuprofen use, which may be particularly pronounced in individuals aged 60 years or older, those with a history of stomach ulcers or bleeding disorders, and patients concurrently using blood thinners or other nonsteroidal anti-inflammatory drugs (NSAIDs).

Additionally, postmarketing reports have suggested an increased risk of cardiovascular events, including heart attack, heart failure, and stroke, associated with NSAID use, including ibuprofen, especially when administered at higher doses or for prolonged durations.

Adverse reactions related to stomach bleeding have been documented, with symptoms such as feeling faint, vomiting blood, having bloody or black stools, and experiencing persistent stomach pain.

Other serious adverse reactions reported include symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, and leg swelling.

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

Patients should be informed about the potential increased risk of heart attack or stroke associated with using the medication in excess of the directed dosage or for a duration longer than recommended. It is essential for patients to consult a doctor before use if they have experienced problems or serious side effects from pain relievers or fever reducers in the past.

Healthcare providers should encourage patients to ask a doctor before use if the warning regarding stomach bleeding applies to them, or if they have a history of stomach issues such as heartburn. Additionally, patients with high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke should be advised to consult a doctor prior to use.

Patients taking a diuretic should also seek medical advice before using the medication. Furthermore, it is important to inform patients that if they are taking aspirin for the prevention of heart attack or stroke, they should consult a doctor or pharmacist, as ibuprofen may diminish the protective effects of aspirin.

Lastly, healthcare providers should remind patients to discuss their current medications with a doctor or pharmacist, especially if they are under medical care for any serious condition or are taking any other drugs.

Storage and Handling

The product is supplied in tamper-evident sealed packets to ensure integrity and safety. It is essential to store the product at a temperature range of 68-77°F (20-25°C). Care should be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40°C (104°F). Opened or torn packets should not be used to maintain product efficacy and safety.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Easy Care First Aid 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 Easy Care First Aid 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

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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.