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Aramark Ibuprofen

Last content change checked dailysee data sync status

This product has been discontinued

Active ingredient
Ibuprofen 200 mg
Other brand names
Dosage form
Tablet
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2021
Label revision date
May 20, 2021
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 200 mg
Other brand names
Dosage form
Tablet
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 2021
Label revision date
May 20, 2021
Manufacturer
Western First Aid Safety DBA Aramark
Registration number
part343
NDC root
81238-0103
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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Drug Overview

Ibuprofen is a medication that belongs to a class known as anti-inflammatory fever reducers. It is commonly used to temporarily relieve minor aches and pains, including headaches, toothaches, menstrual cramps, muscular aches, and minor arthritis pain. Additionally, ibuprofen helps to reduce fever, making it a versatile option for managing discomfort associated with various conditions, such as the common cold.

When you take ibuprofen, it works by blocking certain substances in the body that cause inflammation and pain, providing you with relief from these symptoms. Whether you're dealing with a headache or muscle soreness, ibuprofen can be an effective choice to help you feel better.

Uses

You can use this medication to temporarily relieve minor aches and pains caused by various conditions, including headaches, toothaches, menstrual cramps, muscular aches, and minor arthritis pain. It can also help ease discomfort associated with the common cold. Additionally, this medication is effective in temporarily reducing fever, helping you feel more comfortable when you're not feeling well.

Dosage and Administration

When using this medication, it's important to follow the directions carefully. You should not take more than the recommended amount, and it's best to use the smallest effective dose to manage your symptoms. For adults and children aged 12 years and older, the typical dosage is 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 instead.

However, be cautious not to exceed 6 tablets in a 24-hour period unless your doctor advises otherwise. If you are considering giving this medication to a child under 12 years old, it's essential to consult with a doctor first to ensure it's safe and appropriate for them. Always prioritize your health and safety by following these guidelines.

What to Avoid

You should avoid using this product if you have ever had an allergic reaction to any pain reliever or fever reducer, including this product or any of its ingredients. Additionally, it is important not to use it right before or after heart surgery, as this could pose serious health risks. Always prioritize your safety and consult with a healthcare professional if you have any concerns about using this medication.

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 certain other medications or consuming alcohol regularly.

You should stop using ibuprofen and consult a doctor if you experience signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or if stomach pain persists or worsens. It's also important to seek medical advice before using ibuprofen if you have a history of stomach issues, high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma, or if you are taking other medications like blood thinners or diuretics.

Warnings and Precautions

You should be aware that ibuprofen can cause serious allergic reactions, particularly if you are allergic to aspirin. Signs of an allergic reaction may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, or blisters. Additionally, ibuprofen is a type of nonsteroidal anti-inflammatory drug (NSAID) that can lead to severe stomach bleeding, especially if you are over 60, have a history of stomach ulcers or bleeding, take blood thinners or steroids, use other NSAIDs, consume three or more alcoholic drinks daily, or exceed the recommended dosage.

If you notice any signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain, you should stop using ibuprofen and contact your doctor immediately. It's also important to seek medical advice if your pain lasts more than 10 days, your fever worsens or lasts more than three days, you see redness or swelling in the painful area, or if you develop any new symptoms.

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, or if you are unsure, 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. During the last three months of pregnancy, you should avoid using ibuprofen unless your doctor specifically advises you to do so, as it 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 professional guidance.

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

If your child is under 12 years old, it's important to consult a doctor before using this medication. 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 instead. However, be sure not to exceed 6 tablets in a 24-hour period unless your doctor advises otherwise. Always prioritize safety and seek guidance if you're unsure about the appropriate use for your child.

Geriatric Use

As you consider using this medication, it's important to be aware of certain risks, especially if you are 60 years or older. This product contains a type of pain reliever known as an NSAID (nonsteroidal anti-inflammatory drug), which can increase the risk of severe stomach bleeding. This risk is higher if you have a history of stomach ulcers or bleeding issues, are taking blood thinners (medications that prevent blood clots), or are using other NSAIDs like aspirin or ibuprofen. Additionally, consuming three or more alcoholic drinks daily while using this medication can further elevate this risk.

To stay safe, make sure to follow the dosage instructions carefully and avoid taking the medication for longer than recommended. If you have any concerns or are taking other medications, it’s a good idea to discuss this with your healthcare provider to ensure it’s safe for you.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

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, especially if you're using aspirin to prevent heart attacks or strokes. Additionally, if you're on Warfarin, a blood-thinning medication, combining it with ibuprofen could increase your risk of bleeding.

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

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 avoid exposing it to excessive heat, as temperatures above 40°C (104°F) can damage the product.

When handling the product, make sure to maintain a clean environment to prevent contamination. Always follow any specific instructions provided for safe use and disposal to ensure your safety and the effectiveness of the product.

Additional Information

No further information is available.

FAQ

What is Ibuprofen used for?

Ibuprofen is an anti-inflammatory fever reducer that temporarily relieves minor aches and pains due to headaches, toothaches, menstrual cramps, the common cold, muscular aches, and minor arthritis pain. It also temporarily reduces fever.

What are the directions for taking 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 contraindications for using Ibuprofen?

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

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

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

Can I take Ibuprofen if I am pregnant or breastfeeding?

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

What are the allergy alerts associated with Ibuprofen?

Ibuprofen may cause a severe allergic reaction, especially in those allergic to aspirin. Symptoms can include hives, facial swelling, asthma, shock, skin reddening, rash, and blisters.

What should I do if I have high blood pressure or other serious conditions?

Before using Ibuprofen, consult a doctor if you have high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma, or if you are taking a diuretic.

How should I store Ibuprofen?

Store Ibuprofen at 20-25°C (68-77°F) and avoid excessive heat above 40°C (104°F).

Packaging Info

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

Packaging configurations for Aramark Ibuprofen.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Ibuprofen is an anti-inflammatory and fever-reducing agent manufactured by Aramark, located in Lenexa, KS 66219. The product is packaged in boxes containing 100 tablets, identified by Part # 552R23. The active ingredient in this formulation is comparable to that found in ADVIL® (Registered Trademark of Pfizer Consumer Healthcare). It is advised to retain the carton for complete product information. For inquiries, contact Aramark at (913) 269-9611 or visit their website at aramarkuniform.com.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, toothaches, menstrual cramps, the common cold, 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 administration guidelines. 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 administered. However, it is imperative not to exceed 6 tablets within a 24-hour period unless directed by a healthcare professional.

For children under 12 years of age, it is advised to consult a physician before administration.

Contraindications

Use of this product is contraindicated in the following situations:

  • Patients with a history of allergic reactions to any other pain reliever or fever reducer, as this may increase the risk of a similar reaction.

  • Patients who are scheduled for or have recently undergone heart surgery, due to potential complications associated with its use in this context.

  • Individuals with a known allergy to this product or any of its ingredients, as this poses a significant risk of adverse reactions.

Warnings and Precautions

Ibuprofen is associated with several significant warnings and precautions that healthcare professionals must consider to ensure patient safety.

Allergy Alert Ibuprofen may induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of such reactions can include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Healthcare providers should assess patients for any history of aspirin allergy prior to administration.

Stomach Bleeding Warning As a nonsteroidal anti-inflammatory drug (NSAID), ibuprofen carries a risk of severe stomach bleeding. The likelihood of this adverse effect is heightened in patients who meet any of the following criteria:

  • Are aged 60 years or older

  • Have a history of stomach ulcers or bleeding disorders

  • Are concurrently using anticoagulants or steroid medications

  • Are taking other prescription NSAIDs, including aspirin, ibuprofen, or naproxen

  • Consume three or more alcoholic beverages daily while using this product

  • Exceed the recommended dosage or duration of use

Healthcare professionals should monitor patients closely for signs of gastrointestinal bleeding, particularly in those at increased risk.

Monitoring Parameters Patients should be advised to discontinue use and consult a healthcare provider if they experience any of the following symptoms, which may indicate stomach bleeding:

  • Feeling faint

  • Vomiting blood

  • Presence of bloody or black stools

  • Persistent stomach pain that does not improve

  • Worsening pain or pain lasting more than 10 days

  • Fever that worsens or lasts more than three days

  • Redness or swelling in the affected area

  • Any new or unusual symptoms

Prompt recognition and management of these symptoms are crucial to prevent serious complications associated with ibuprofen use.

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 hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters.

Additionally, ibuprofen, as a nonsteroidal anti-inflammatory drug (NSAID), carries a warning for the potential risk of severe stomach bleeding. The likelihood of this adverse reaction is increased in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding problems, are taking anticoagulants or steroid medications, are using other NSAIDs (such as aspirin, ibuprofen, or naproxen), consume three or more alcoholic drinks daily while using this product, or exceed the recommended dosage or duration of use.

Patients are advised to discontinue use and consult a healthcare professional if they experience any signs of stomach bleeding, which may manifest as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain that worsens or lasts longer than 10 days. Other concerning symptoms include a fever that worsens or lasts more than three days, redness or swelling in the painful area, or the emergence of any new symptoms.

Before using ibuprofen, patients should seek medical advice if they fall into any of the following categories: those for whom the stomach bleeding warning applies, individuals with a history of adverse reactions to pain relievers or fever reducers, those with a history of stomach problems such as heartburn, and patients with high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Additionally, individuals taking diuretics should consult a healthcare provider prior to use.

It is also recommended that patients under a physician's care for any serious condition, or those taking aspirin for the prevention of heart attack or stroke, seek medical advice before using ibuprofen, as it may diminish the effectiveness of aspirin. Furthermore, patients taking the anticoagulant Warfarin should consult a healthcare professional prior to use.

Drug Interactions

Ibuprofen may diminish the cardioprotective effects of aspirin when both medications are administered concurrently for the prevention of heart attack or stroke. It is advisable to avoid the simultaneous use of ibuprofen and aspirin in patients requiring aspirin for cardiovascular protection.

Additionally, the concomitant use of ibuprofen with the anticoagulant Warfarin may elevate the risk of bleeding complications. Close monitoring of coagulation parameters is recommended in patients receiving this combination, and dosage adjustments of either medication may be necessary based on clinical judgment and patient response.

Packaging & NDC

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

Packaging configurations for Aramark 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 while symptoms persist. If pain or fever does not adequately respond to 1 tablet, a dose of 2 tablets may be administered. It is important not to exceed 6 tablets within a 24-hour period unless directed by a healthcare provider.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk of severe stomach bleeding when using this product, which contains a nonsteroidal anti-inflammatory drug (NSAID). This risk is further heightened in individuals with a history of stomach ulcers or bleeding problems, those who are concurrently using blood-thinning medications (anticoagulants) or steroid drugs, and patients taking other NSAIDs, including prescription medications such as aspirin, ibuprofen, or naproxen.

Healthcare providers should exercise caution when prescribing this product to geriatric patients, especially if they consume three or more alcoholic drinks daily while using the medication. It is essential to monitor these patients closely for any signs of gastrointestinal bleeding and to consider dose modifications or alternative therapies as appropriate. Additionally, adherence to the recommended dosage and duration of treatment is crucial to minimize the risk of adverse effects in 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 explicitly 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 before using this medication while breastfeeding. It is particularly important to avoid the use of ibuprofen during the last three months of pregnancy unless specifically directed by a healthcare provider, 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, caution is recommended when considering its use in lactating individuals.

Renal Impairment

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution when prescribing to patients with renal impairment, as the absence of detailed guidance necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

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.

If available, specific antidotes or treatments should be administered as indicated based on the clinical scenario and the substance involved. Consultation with a poison control center or a medical toxicologist may be beneficial for guidance on management strategies tailored to the specific situation.

Documentation of the incident, including the substance involved, estimated dose, time of exposure, and any symptoms observed, is crucial for effective management and follow-up care.

Nonclinical Toxicology

It is especially important not to use ibuprofen during the last three months of pregnancy unless specifically directed by a healthcare professional, as it may lead to complications for the unborn child or 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

No specific postmarketing experience details are available. As such, there are no additional adverse events or rare case reports to summarize at this time.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help or contact a Poison Control Center immediately.

Patients should be cautioned against using this medication if they have a history of allergic reactions to any other pain reliever or fever reducer, or if they have previously experienced an allergic reaction to this product or any of its ingredients. Additionally, it is important to inform patients that they should not use this medication right before or after heart surgery.

Healthcare providers should instruct patients to discontinue use and consult a doctor if they experience any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, experiencing stomach pain that does not improve, or if pain worsens or lasts more than 10 days. Patients should also be advised to seek medical attention if fever worsens or lasts more than 3 days, if redness or swelling occurs in the painful area, or if any new symptoms arise.

When using this product, patients should be informed to take it with food or milk if they experience stomach upset. They should also be made aware that the risk of heart attack or stroke may increase if they use more than the recommended dose or for a longer duration than directed.

Healthcare providers should encourage patients to consult a doctor before use if the warning regarding stomach bleeding applies to them, if they have experienced problems or serious side effects from pain relievers or fever reducers, or if they have a history of stomach issues such as heartburn. Patients with high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma, as well as those taking a diuretic, should also seek medical advice prior to use.

Finally, patients should be advised to consult a doctor or pharmacist before using this medication if they are under a doctor’s care for any serious condition, are taking aspirin for heart attack or stroke (as ibuprofen may reduce the effectiveness of aspirin), or are using the blood-thinning medication Warfarin.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a temperature range of 20-25°C (68-77°F) to maintain its efficacy. Care should be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40°C (104°F), as this may compromise the product's integrity. Proper storage conditions are crucial for ensuring the quality and safety of the product throughout its shelf life.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Aramark 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 Aramark 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.