Dragon

Description

Dragon Tabs contain Ibuprofen at a dosage of 200 mg per tablet. This nonsteroidal anti-inflammatory drug (NSAID) is indicated for the temporary relief of pain and reduction of fever. It is effective in alleviating backache and muscular aches. Each bottle contains 40 tablets.

Uses and Indications

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

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

Dosage and Administration

Adults and children 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 specifically 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 induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of such reactions include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Should any of these symptoms manifest, 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 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 anticoagulants or steroid medications, 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 advise patients to discontinue use and consult a physician if they experience any of the following: fainting, vomiting blood, or passing bloody or black stools, as these may be signs of stomach bleeding; worsening pain or pain persisting beyond 10 days; fever that worsens or lasts more than 3 days; exacerbation of stomach pain or upset; presence of redness or swelling in the affected area; or the emergence of any new symptoms.

In the event of an overdose, immediate medical attention is required. Patients or caregivers should contact a Poison Control Center at 1-800-222-1222 without delay.

Side Effects

Patients using ibuprofen should be aware of the potential for serious adverse reactions, including severe allergic reactions and gastrointestinal complications.

Serious Adverse Reactions Ibuprofen may cause a severe allergic reaction, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions can include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. In the event of an allergic reaction, patients are advised to discontinue use immediately and seek medical assistance.

Additionally, ibuprofen, as a nonsteroidal anti-inflammatory drug (NSAID), carries a warning for the 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 while using the product, or exceed the recommended dosage or duration of use.

Patients should stop using ibuprofen and consult a healthcare provider if they experience symptoms indicative of stomach bleeding, such as fainting, vomiting blood, or passing bloody or black stools. Other concerning symptoms that warrant medical consultation include worsening pain lasting more than 10 days, fever persisting beyond 3 days, worsening stomach pain or upset, redness or swelling in the painful area, or the emergence of any new symptoms.

Common Adverse Reactions Long-term continuous use of ibuprofen may increase the risk of heart attack or stroke. Therefore, it is crucial for patients to discuss their medical history with a healthcare provider before using ibuprofen, especially if they have a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma.

Patients are also advised to consult a doctor or pharmacist before using ibuprofen if they are taking any other NSAIDs, anticoagulants, or steroid medications, or if they are under medical care for any serious condition.

Pregnancy Considerations It is particularly important for patients to avoid using 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.

Drug Interactions

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking any other nonsteroidal anti-inflammatory drugs (NSAIDs), whether prescription or over-the-counter. The combination of NSAIDs may increase the risk of adverse effects, including gastrointestinal bleeding and renal impairment.

Additionally, individuals taking anticoagulants or steroid medications should seek advice from a healthcare provider before initiating treatment with this drug. The concomitant use of these agents may enhance the risk of bleeding or other significant interactions, necessitating careful monitoring and potential dosage adjustments.

Packaging & NDC

Below are the non-prescription pack sizes of Dragon (ibuprofen 200 mg). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

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 for symptom relief. 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 stomach bleeding. It is advisable for these patients to consult a healthcare provider before using this medication if they are concerned about the stomach bleeding warning.

Additionally, long-term continuous use of this medication may elevate the risk of heart attack or stroke, especially in older adults. Therefore, careful monitoring and consideration of the benefits versus risks are essential when prescribing this medication to geriatric patients. Dose adjustments may be necessary based on individual patient assessments and clinical judgment.

Pregnancy

Pregnant patients should consult a healthcare professional before using this medication, particularly if they are in the later stages of pregnancy or breastfeeding. The use of ibuprofen during the last trimester is contraindicated unless specifically directed by a physician, as it may pose risks to the developing fetus and lead to complications during delivery. Healthcare providers should carefully evaluate the potential benefits and risks when considering the use of this medication in pregnant patients.

Lactation

Lactating mothers are advised to consult a 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 ibuprofen in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering the use of this medication in 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 kidney disease. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the severity of renal impairment.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to use, particularly if they have a history of liver cirrhosis. It is essential for these patients to receive appropriate evaluation and monitoring of liver function to ensure safe use of the medication. Adjustments to dosage may be necessary based on the severity of hepatic impairment, and ongoing assessment of liver function is recommended throughout the treatment period.

Overdosage

Overdosage of ibuprofen may result in significant harm to the patient. Healthcare professionals should be aware of the potential symptoms associated with an overdose, which can include nausea, vomiting, stomach pain, drowsiness, headache, and confusion.

In the event of an overdose, it is imperative to seek immediate medical attention. Healthcare providers should advise patients or caregivers to contact a Poison Control Center for further guidance and management. Prompt intervention is crucial to mitigate the risks associated with ibuprofen overdosage and to ensure appropriate care is administered.

Nonclinical Toxicology

It is especially important not to use ibuprofen during the last three months of pregnancy unless definitely directed to do so by a doctor, as it may cause problems in the unborn child or complications during delivery. No non-teratogenic effects have been specified in the available data. Additionally, there are no details provided regarding animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the medication. Reports include gastrointestinal bleeding, renal impairment, and elevations in liver enzymes. Additionally, cases of anaphylaxis and serious skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have been documented.

Cardiovascular events, including myocardial infarction and stroke, have been observed in patients using ibuprofen. There have also been reports of hypertension and heart failure among individuals taking ibuprofen. Furthermore, instances of asthma exacerbation have been noted in patients with a prior history of asthma. Hepatic reactions, including jaundice and hepatitis, have also been reported in the postmarketing experience.

Patient Counseling

Patients should be advised to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is recommended that patients take the medication with food or milk if they experience stomach upset.

Healthcare providers should inform patients that long-term continuous use of this medication may increase the risk of heart attack or stroke. Patients should be encouraged to consult with their doctor before using this medication if they have experienced problems or serious side effects from pain relievers or fever reducers in the past.

Patients should also be advised to discuss their medical history with their healthcare provider, particularly if they have a history of stomach problems, such as heartburn, or if the stomach bleeding warning applies to them. It is important for patients with high blood pressure, heart disease, liver cirrhosis, or kidney disease to consult their doctor prior to use. Additionally, patients with asthma should seek medical advice before starting this medication.

Patients taking diuretics, blood thinners (anticoagulants), or steroid drugs should be instructed to consult their doctor or pharmacist before use. Furthermore, patients should be encouraged to discuss any other medications they are taking, including both prescription and nonprescription NSAIDs, with their healthcare provider to ensure safe use. Lastly, patients under a doctor's care for any serious condition should also seek guidance before using this medication.

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) to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature range to prevent degradation.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)