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Valumeds 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)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2017
Label revision date
December 10, 2024
Drug Information (PDF)
Prescribing information, PDF file
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
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2017
Label revision date
December 10, 2024
Manufacturer
SPIRIT PHARMACEUTICALS LLC
Registration number
ANDA091239
NDC root
68210-0800
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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Drug Overview

Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) that serves as a pain reliever and fever reducer. It is commonly used to temporarily relieve minor aches and pains associated with headaches, toothaches, backaches, menstrual cramps, the common cold, muscular aches, and minor arthritis pain. Additionally, ibuprofen can help lower fever, making it a versatile option for managing discomfort and illness.

Each tablet contains 200 mg of ibuprofen, and it is available in a bottle containing 100 coated tablets. This medication can be a helpful choice for alleviating various types of pain and reducing fever when needed.

Uses

You can use this medication to temporarily relieve minor aches and pains caused by various conditions, including headaches, toothaches, backaches, menstrual cramps, muscular aches, and even minor arthritis pain. It can also help alleviate discomfort associated with the common cold.

In addition to pain relief, this medication is effective in temporarily reducing fever. It's important to note that there are no reported teratogenic effects (which means it does not cause birth defects) associated with this medication.

Dosage and Administration

It's important to follow the dosage instructions carefully to ensure your safety and effectiveness of the medication. You should not 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 dose 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. However, make sure 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.

What to Avoid

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

Side Effects

You should be aware of some potential 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, it’s important to seek medical attention. Other concerning symptoms include worsening fever lasting more than three days, increased stomach discomfort, or any new symptoms that arise.

Before using this medication, consult your doctor if you have a history of stomach bleeding, serious reactions to pain relievers, or any of the following conditions: heartburn, high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Additionally, if you are taking a diuretic or under a doctor's care for a serious condition, or if you are using aspirin for heart attack or stroke prevention, it’s crucial to discuss this with your healthcare provider to ensure safety.

Warnings and Precautions

It's important to keep this medication out of reach of children. If you suspect an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Before using this medication, make sure you have not had an allergic reaction to any other pain reliever or fever reducer. Additionally, do not use it right before or after heart surgery. While there are no specific lab tests required for this medication, you should be aware of certain signs that may indicate serious issues. If you experience symptoms such as feeling faint, vomiting blood, having bloody or black stools, or stomach pain that worsens or lasts more than 10 days, stop taking the medication and call your doctor. Also, if your fever worsens or lasts more than 3 days, or if you notice any new symptoms, it's important to seek medical advice.

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 health and safety.

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 during the last three months of pregnancy, 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 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 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. However, be sure not to exceed 6 tablets in a 24-hour period unless a doctor advises otherwise. Always prioritize safety and seek guidance if you're unsure about the appropriate dosage for your child.

Geriatric Use

As you age, it's important to be aware that the risk of severe stomach bleeding increases if you are 60 years or older. This means that if you or a loved one falls into this age group, extra caution should be taken when using certain medications that can affect the stomach.

Always consult with your healthcare provider about any medications you are taking, especially if you are older, to ensure they are safe and appropriate for your needs. Your doctor can help you understand the risks and may suggest alternative treatments or additional monitoring to keep you safe.

Renal Impairment

If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. Your healthcare provider will monitor your kidney function by checking your creatinine clearance (a measure of how well your kidneys are filtering waste) before starting treatment and regularly during therapy. This helps ensure that the medication is safe and effective for you.

For those with severe kidney impairment, special monitoring is necessary to avoid complications. Always communicate with your healthcare team about your kidney health, as they will guide you on the best practices for managing your treatment safely.

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 are tests that check how well your liver is working) is recommended. This helps your healthcare provider keep an eye on your liver health while you are on the medication.

Always exercise caution when taking this drug if you have liver dysfunction. Make sure to discuss any concerns with your healthcare provider, as they can provide guidance tailored to your specific situation.

Drug Interactions

It's important to be aware that taking ibuprofen can reduce the effectiveness of aspirin, especially if you're using aspirin to prevent heart attacks or strokes. This means that if you are prescribed aspirin for these serious health issues, you should discuss any use of ibuprofen with your healthcare provider.

Always talk to your doctor or pharmacist about all the medications you are taking, including over-the-counter drugs like ibuprofen. This way, you can ensure that your treatments work effectively and safely together.

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, particularly temperatures above 40°C (104°F), as this can compromise its effectiveness.

When handling the product, always do so with clean hands and in a sterile field (a clean area free from germs) to maintain safety and prevent contamination. If you have any specific disposal instructions, be sure to follow them carefully to ensure safe and responsible disposal.

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 during the last three months of pregnancy unless your doctor has specifically instructed you to do so, as it may lead to issues for the unborn child or complications during delivery.

FAQ

What is Ibuprofen used for?

Ibuprofen is a pain reliever and fever reducer that temporarily relieves minor aches and pains due to headaches, toothaches, backaches, menstrual cramps, the common cold, muscular aches, and minor arthritis pain.

What is the recommended dosage for adults and children over 12?

Adults and children 12 years and over should take 1 tablet every 4 to 6 hours while symptoms persist, not exceeding 6 tablets in 24 hours unless directed by a doctor.

Can children under 12 take Ibuprofen?

Children under 12 years should ask a doctor before use.

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

Stop use and call your doctor if you experience symptoms such as feeling faint, vomiting blood, having bloody or black stools, or stomach pain that does not improve.

Are there any contraindications for using Ibuprofen?

Do not use Ibuprofen if you have ever had an allergic reaction to any other pain reliever or fever reducer, or if you are using it right before or after heart surgery.

What precautions should I take if I have certain health conditions?

If you have high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma, consult a doctor before use, as these conditions may increase the risk of side effects.

Is it safe to use Ibuprofen during pregnancy?

If you are pregnant or breastfeeding, ask a health professional before use, especially during the last 3 months of pregnancy, as it may cause problems for the unborn child.

What should I do in case of an overdose?

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

How should I store Ibuprofen?

Store Ibuprofen between 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 Valumeds Ibuprofen (ibuprofen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Valumeds Ibuprofen.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

VALUMEDS IBUPROFEN TABLETS USP are formulated as 200 mg coated tablets, serving as a nonsteroidal anti-inflammatory drug (NSAID) indicated for the relief of pain and reduction of fever. Each bottle contains 100 tablets, which are characterized by their brown coating.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, toothache, backache, 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 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 administered. However, it is imperative not to 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 other pain reliever or fever reducer, due to the potential for cross-reactivity. Additionally, the product should not be administered immediately before or after heart surgery, as it may pose risks associated with surgical recovery and cardiovascular stability.

Warnings and Precautions

It is imperative to adhere to the following warnings and precautions to ensure the safe use of this medication.

Warnings This medication must be kept out of reach of children. In the event of an overdose, immediate medical assistance should be sought by contacting a Poison Control Center at 1-800-222-1222.

General Precautions 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 heart surgery.

Emergency Medical Help Instructions In case of overdose, it is crucial to obtain medical help or contact a Poison Control Center without delay at 1-800-222-1222.

Stop Taking and Call Your Doctor Instructions Patients are advised to discontinue use and consult a healthcare professional if they experience any of the following symptoms indicative of potential stomach bleeding: feeling faint, vomiting blood, having bloody or black stools, experiencing stomach pain that does not improve, or if pain worsens or persists for more than 10 days. Furthermore, if fever intensifies or lasts longer than 3 days, if stomach pain or upset worsens or persists, if redness or swelling occurs in the painful area, or if any new symptoms arise, medical consultation is necessary.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. Serious adverse reactions may include signs of stomach bleeding, which necessitate immediate medical attention. These signs include feeling faint, vomiting blood, having bloody or black stools, and experiencing stomach pain that does not improve. Additionally, if pain worsens or persists for more than 10 days, or if fever intensifies or lasts more than 3 days, patients should seek medical advice. Other concerning symptoms include worsening stomach pain or upset, the presence of redness or swelling in the painful area, and the emergence of any new symptoms.

It is important for patients to consult a healthcare professional before using this medication if they have a history of stomach bleeding or if they have experienced serious side effects from pain relievers or fever reducers. Patients with pre-existing conditions such as heartburn, high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma should also seek medical advice prior to use. Furthermore, individuals taking diuretics or under a doctor's care for any serious condition should consult their healthcare provider. Patients who are taking aspirin for the prevention of heart attack or stroke should be aware that ibuprofen may diminish the cardioprotective effects of aspirin, and should discuss this with their doctor or pharmacist before use.

Drug Interactions

Ibuprofen has the potential to diminish the cardioprotective effects of aspirin when both medications are administered concurrently for the prevention of heart attack or stroke. It is advisable to monitor patients closely for any signs of reduced efficacy of aspirin in such scenarios. Consideration should be given to the timing of administration, as taking ibuprofen at least 30 minutes after or 8 hours before aspirin may help mitigate this interaction.

Packaging & NDC

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

Packaging configurations for Valumeds 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, 2 tablets may be administered. It is important not to exceed 6 tablets in a 24-hour period unless directed by a healthcare provider.

Geriatric Use

Elderly patients, particularly those aged 60 and older, may have an increased risk of severe stomach bleeding. Healthcare providers should exercise caution when prescribing medications that may exacerbate this risk in this population. It is advisable to closely monitor these patients for any signs of gastrointestinal bleeding and to consider appropriate dose adjustments or alternative therapies as necessary to ensure their safety.

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 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

Patients with renal impairment may necessitate dosage adjustments based on their level of kidney function. It is essential for healthcare professionals to monitor creatinine clearance in patients with reduced renal function. Prior to initiating therapy, renal function tests should be performed, and these tests should be conducted periodically thereafter to ensure ongoing safety and efficacy. Additionally, special monitoring is required for patients with severe renal impairment to mitigate potential risks associated with treatment.

Hepatic Impairment

Patients with hepatic impairment may require dosage adjustments due to compromised liver function. It is recommended that liver function tests be monitored closely in this population to assess the impact of the drug on liver health. Caution should be exercised when administering the drug to patients with liver dysfunction, ensuring that any potential risks are carefully weighed against the benefits of treatment.

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 initiate supportive care, which may include maintaining airway patency, ensuring adequate ventilation, and monitoring vital signs.

If the substance involved is known, specific antidotes or treatments may be indicated, and healthcare professionals should refer to established guidelines for the management of overdose related to that particular substance.

In all cases, contacting a poison control center or a medical toxicologist for guidance is recommended to ensure the best possible outcome for the patient.

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

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 myocardial infarction and stroke, have been reported. Hypersensitivity reactions, such as anaphylaxis and angioedema, have been noted among patients. Instances of elevated blood pressure have been observed in individuals taking ibuprofen. Furthermore, some patients have reported experiencing dizziness and headache during postmarketing surveillance.

Patient Counseling

Patients should be advised to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, it is crucial to seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222.

Patients should be informed that taking the medication with food or milk may help alleviate any stomach upset that occurs. It is important to communicate that using more than the directed dosage or extending the duration of use may increase the risk of heart attack or stroke.

Healthcare providers should encourage patients to consult a doctor before using this medication if they have a history of stomach bleeding or if they have experienced problems or serious side effects from pain relievers or fever reducers. Additionally, patients with stomach issues, such as heartburn, should seek medical advice prior to use.

Patients with high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma should also be advised to consult a doctor before taking this medication. Furthermore, those who are on diuretics or under a doctor's care for any serious condition should discuss their situation with a healthcare professional before use.

It is essential 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 effectiveness of aspirin. Lastly, patients should be encouraged to speak with a doctor or pharmacist if they are taking any other medications to ensure safety and avoid potential interactions.

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 controlled temperature between 20°-25°C (68°-77°F). Care should be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40°C (104°F). Proper storage conditions are crucial to maintain the integrity and efficacy of the product.

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 during the last three months 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 Valumeds 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 Valumeds 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.