Symptom checker
Select audience type

Switch between content for healthcare professionals (PRO) and general audience (GEN).

ADD CONDITION

items per page

Ibuwin Forte

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
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2023
Label revision date
December 29, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 200 mg
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
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 2023
Label revision date
December 29, 2023
Manufacturer
OPMX LLC
Registration number
ANDA079174
NDC root
69729-157
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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

Ibuwin Forte is a medication that contains ibuprofen (a type of pain reliever and fever reducer) at a strength of 200 mg. It is classified as a nonsteroidal anti-inflammatory drug (NSAID), which means it helps to alleviate pain and reduce inflammation.

You can use Ibuwin Forte to temporarily relieve minor aches and pains from various conditions, including headaches, toothaches, backaches, menstrual cramps, muscular aches, and minor arthritis pain. Additionally, it can help lower fever, making it a versatile option for managing discomfort and illness.

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 ease discomfort associated with the common cold.

In addition to pain relief, this medication is effective in temporarily reducing fever, helping you feel more comfortable when you're not feeling well.

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 your pain or fever doesn’t improve with just 1 caplet, you may take 2 caplets instead. However, it’s important not to exceed 6 caplets in a 24-hour period unless your doctor advises 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 any other pain reliever or fever reducer. Additionally, it is important not to use it right before or after heart surgery, as this could pose serious risks to your health.

Be cautious about the dosage; using more than directed or for longer than recommended may increase your risk of a heart attack. Always follow the instructions provided to ensure your safety and well-being.

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, wheezing (asthma), shock, skin reddening, rash, and blisters. Additionally, this medication carries a risk of severe stomach bleeding, especially for those over 60, with a history of stomach ulcers or bleeding, or who consume alcohol regularly. The risk of heart attack and stroke is also increased with the use of NSAIDs like ibuprofen, 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, having bloody or black stools, vomiting blood, or experiencing persistent stomach pain. 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, especially blood thinners or diuretics.

Warnings and Precautions

Ibuprofen can cause serious allergic reactions, especially if you are allergic to aspirin. Symptoms may include hives, facial swelling, wheezing, shock, skin reddening, rash, or blisters. If you experience any of these symptoms, stop using ibuprofen immediately and seek medical help.

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, having bloody or black stools, vomiting blood, or experiencing persistent stomach pain, stop using ibuprofen and call your doctor. It's important to seek emergency medical help in case of an overdose or if you have any concerning symptoms.

Overdose

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

Don’t wait for symptoms to worsen; acting quickly can make a significant difference in your safety. Always keep emergency contact information handy, and remember that it’s better to be cautious when it comes to your health.

Pregnancy Use

If you are pregnant or breastfeeding, it’s crucial to consult with a healthcare professional before using any medication, including ibuprofen. This is particularly important 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 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 during the last three months of pregnancy, as using ibuprofen at 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.

Pediatric Use

If your child is under 12 years old, it's important to consult with a doctor before using this medication. For those aged 12 and older, the recommended dosage is one caplet every 4 to 6 hours as needed for symptoms. If one caplet does not relieve pain or fever, you may take two caplets. However, be sure not to exceed six caplets in a 24-hour period unless your doctor advises otherwise. Always prioritize safety and seek professional guidance when it comes to treating your child's health.

Geriatric Use

As you age, it's important to be aware that the risk of stomach bleeding increases if you are 60 years or older. This means that if you or a loved one falls into this age group, you should be particularly cautious about medications that may affect your stomach. Always consult with your healthcare provider about any medications you are taking, as they can help you understand the risks and adjust dosages if necessary to ensure your safety. Taking these precautions can help you manage your health more effectively.

Renal Impairment

If you have kidney problems, it's important to consult your doctor before using this medication. This is especially crucial if you also have high blood pressure, heart disease, liver cirrhosis (a severe liver condition), or asthma. Your healthcare provider can help determine if this medication is safe for you and whether any adjustments to your dosage or monitoring are necessary. Always prioritize your health by discussing any existing conditions with your doctor.

Hepatic Impairment

If you have liver problems, such as liver cirrhosis (a severe scarring of the liver), it's important to consult your doctor before using this medication. Your healthcare provider will assess your overall health and may need to adjust your dosage or monitor your condition more closely. This is crucial to ensure your safety and the effectiveness of the treatment. Always keep your doctor informed about any existing health issues, including high blood pressure, heart disease, kidney disease, or asthma, as these can also affect your treatment plan.

Drug Interactions

It's important to talk to your healthcare provider about any medications you are taking, especially if you are using ibuprofen. For instance, if you take aspirin for heart health, using ibuprofen may reduce the benefits of aspirin. Additionally, combining ibuprofen with blood thinners (medications that prevent blood clots) or steroids can increase the risk of stomach bleeding. You should also be cautious if you are taking other nonsteroidal anti-inflammatory drugs (NSAIDs), like aspirin or naproxen, alongside ibuprofen, as this can further heighten the risk of stomach issues.

Always keep your healthcare provider informed about all the medications you are using to ensure your safety and the effectiveness of your treatments.

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 excessive heat, as temperatures above 40°C (104°F) can damage it.

When handling the product, always check that the safety seal is intact. If the seal is broken or missing, do not use the product, as this indicates it may have been tampered with. Following these guidelines will help maintain the product's safety and effectiveness.

Additional Information

You should take this medication orally. If you are pregnant or breastfeeding, it’s important to consult with 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 Ibuwin Forte used for?

Ibuwin Forte is used to temporarily relieve minor aches and pains from headaches, toothaches, backaches, menstrual cramps, the common cold, muscular aches, and minor arthritis pain. It also temporarily reduces fever.

What is the active ingredient in Ibuwin Forte?

The active ingredient in Ibuwin Forte is Ibuprofen, which is 200 mg per caplet.

How should adults and children 12 years and older take Ibuwin Forte?

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, 2 caplets may be used, but do not exceed 6 caplets in 24 hours unless directed by a doctor.

Are there any warnings associated with Ibuwin Forte?

Yes, Ibuwin Forte may cause severe allergic reactions, stomach bleeding, and increase the risk of heart attack and stroke. You should stop use and call a doctor if you experience signs of stomach bleeding or if symptoms worsen.

Can I use Ibuwin Forte if I am pregnant or breastfeeding?

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

What should I do if I experience an allergic reaction to Ibuwin Forte?

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

What should I avoid while taking Ibuwin Forte?

You should avoid taking Ibuwin Forte if you have had an allergic reaction to any other pain reliever or fever reducer, or if you are using it right before or after heart surgery.

How should I store Ibuwin Forte?

Store Ibuwin Forte at 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 Ibuwin Forte (ibuprofen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Ibuwin Forte.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Ibuwin Forte is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the relief of pain and reduction of fever. Each tablet contains 200 mg of ibuprofen as the active ingredient. The product is available in a package containing 10 tablets. The National Drug Code (NDC) for Ibuwin Forte is 69729-157-10.

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

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

Warnings and Precautions

Ibuprofen may 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.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of severe stomach bleeding. The likelihood of experiencing this adverse effect is heightened in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding disorders, are concurrently using blood-thinning medications (anticoagulants) or steroid drugs, are taking 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.

Healthcare professionals should be aware that NSAIDs, excluding aspirin, are associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is amplified when the medication is used in excess of the recommended dosage or for an extended period.

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

Patients should be instructed to discontinue use and consult their healthcare provider if they experience any signs of stomach bleeding, which may include feeling faint, having bloody or black stools, vomiting blood, experiencing persistent stomach pain, or if pain worsens or lasts longer than 10 days. Additionally, if fever worsens or persists beyond three days, or if redness or swelling occurs in the painful area, or if any new symptoms arise, medical advice should be sought promptly.

Side Effects

Patients using ibuprofen may experience a range of adverse reactions, which can vary in 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.

The use of ibuprofen, as a nonsteroidal anti-inflammatory drug (NSAID), carries a significant risk of severe stomach bleeding. This risk is heightened in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding problems, are taking anticoagulants or steroid medications, consume three or more alcoholic drinks daily, 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. This risk is particularly pronounced in patients who use ibuprofen in higher doses or for extended periods.

Patients are advised to discontinue use and consult a healthcare professional if they experience any signs of stomach bleeding, such as feeling faint, having bloody or black stools, vomiting blood, experiencing persistent stomach pain, or if pain 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 have a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma, or if they are taking diuretics. It is also recommended that patients under a doctor's care for serious conditions or those taking aspirin for heart attack or stroke consult a healthcare professional, as ibuprofen may diminish the cardioprotective effects of aspirin.

Drug Interactions

The concomitant use of ibuprofen with aspirin, particularly in the context of cardiovascular events such as heart attack or stroke, may diminish the antiplatelet efficacy of aspirin. Therefore, it is advisable to avoid the simultaneous administration of these medications to ensure optimal therapeutic outcomes.

When ibuprofen is used in conjunction with anticoagulants or steroid medications, there is an increased risk of gastrointestinal bleeding. Clinicians should exercise caution and consider monitoring patients for signs of bleeding, as well as evaluating the necessity of dosage adjustments based on individual patient risk factors.

Additionally, the co-administration of ibuprofen with other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as aspirin and naproxen, heightens the risk of stomach bleeding. It is recommended that healthcare providers assess the need for alternative pain management strategies or implement close monitoring for gastrointestinal complications in patients requiring multiple NSAID therapies.

No specific interactions with laboratory tests have been identified in the available data.

Packaging & NDC

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

Packaging configurations for Ibuwin Forte.
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 caplet every 4 to 6 hours as needed for symptom relief. If pain or fever does not adequately respond to 1 caplet, 2 caplets may be administered. It is important not to exceed 6 caplets within a 24-hour period unless otherwise directed by a healthcare provider.

Geriatric Use

Elderly patients, particularly those aged 60 years and older, may have an increased risk of 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 should consult a healthcare professional before using this medication, particularly if they are in the later stages of pregnancy or breastfeeding. It is especially important to avoid the use of ibuprofen during the last trimester unless specifically directed by a physician, as it may pose risks to the developing fetus and lead to complications during delivery. Healthcare providers should weigh the potential benefits against the risks when considering the use of this medication in pregnant patients.

Lactation

Lactating mothers are advised to consult a health professional before using this medication. It is particularly important to avoid the use of 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. There is no specific data provided regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, healthcare providers should exercise caution and consider the potential risks and benefits when advising lactating mothers.

Renal Impairment

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

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to use, particularly if they have conditions such as liver cirrhosis. It is essential for these patients to receive appropriate medical guidance to assess the potential risks and benefits associated with the use of this medication. Monitoring of liver function may be necessary to ensure safety and efficacy in this population. Adjustments to dosage or treatment regimens may be required based on the severity of hepatic impairment and the patient's overall health status.

Overdosage

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

Healthcare professionals should be vigilant in monitoring for symptoms that may arise from an overdose. While specific symptoms are not detailed in the provided information, it is essential to remain alert to any signs of toxicity or adverse reactions that may develop.

Management of an overdose should be guided by established protocols, which may include supportive care and symptomatic treatment as necessary. The involvement of poison control experts can provide additional guidance on the appropriate management strategies tailored to the specific circumstances of the overdose.

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 detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs.

Allergic reactions have been noted, including hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Additionally, cases of stomach bleeding have been reported, particularly in patients aged 60 or older, those with a history of stomach ulcers or bleeding problems, individuals taking blood-thinning (anticoagulant) or steroid medications, users of other NSAIDs, those consuming three or more alcoholic drinks daily, or patients exceeding the recommended dosage.

Furthermore, there is an increased risk of heart attack, heart failure, and stroke associated with NSAID use, especially when used beyond the recommended duration or dosage.

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 crucial for patients to understand the importance of timely intervention in such situations.

Patients should also be informed that if they experience stomach upset, taking the medication with food or milk may help alleviate discomfort. This guidance can enhance patient compliance and comfort during treatment.

Additionally, healthcare providers should discuss the potential risks associated with the medication, specifically the increased risk of heart attack if the patient uses more than the recommended dose or for a duration longer than prescribed. Emphasizing adherence to the prescribed dosage and duration is essential for ensuring patient safety and minimizing adverse effects.

Storage and Handling

The product is supplied in a configuration that ensures tamper evidence; it should not be used if the imprinted safety seal is broken or missing.

For optimal storage, the product must be maintained at a temperature range of 20-25°C (68-77°F). It is essential to avoid exposure to high humidity and excessive heat, specifically temperatures exceeding 40°C (104°F), to preserve the integrity of the product. Proper handling and storage conditions are critical to ensure the product's efficacy and safety.

Additional Clinical Information

The route of administration for the medication is oral. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is particularly crucial to avoid ibuprofen 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. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Ibuwin Forte, 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 Ibuwin Forte, 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.