Unishield Ibuprofen

Description

No description information is available for the specified drug.

Uses and Indications

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

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

Dosage and Administration

Adults and children aged 12 years and older are advised to take 1 tablet every 4 to 6 hours as needed while symptoms persist. In cases where pain or fever does not adequately respond to 1 tablet, a dosage of 2 tablets may be administered. It is imperative that the total daily dosage does not exceed 6 tablets within a 24-hour period, unless otherwise directed by a healthcare professional.

For children under 12 years of age, 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 elicit severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of such reactions include hives, skin reddening, asthma (wheezing), facial swelling, rash, shock, 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 this adverse effect is heightened in patients who 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 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.

Furthermore, NSAIDs, excluding aspirin, are associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk escalates with the use of higher doses or prolonged treatment.

Healthcare professionals should advise patients to discontinue use and consult a physician if they experience any signs of stomach bleeding, such as feeling faint, vomiting blood, or having bloody or black stools. Additional symptoms warranting medical consultation include persistent stomach pain, signs of heart problems or stroke (such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling), worsening pain lasting more than 10 days, fever that worsens or persists beyond three days, redness or swelling in the affected area, or any new or unexpected symptoms.

In cases of overdose, immediate medical attention is required, and patients should contact a Poison Control Center without delay.

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

The use of ibuprofen is associated with an increased risk of serious gastrointestinal events, including severe stomach bleeding. This risk is heightened in patients who are aged 60 years 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, ibuprofen, as a nonsteroidal anti-inflammatory drug (NSAID), carries warnings regarding cardiovascular risks. The use of NSAIDs, excluding aspirin, has been linked to an elevated risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced in patients who use the medication in excess of the recommended guidelines.

Patients are advised to discontinue use and consult a healthcare professional if they experience any signs of stomach bleeding, such as feeling faint, vomiting blood, or having bloody or black stools. Other concerning symptoms that warrant medical attention include persistent stomach pain, signs of heart problems or stroke (such as chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or leg swelling), worsening pain lasting more than 10 days, fever lasting more than 3 days, redness or swelling in the painful area, or any new or unexpected symptoms.

Before initiating treatment with ibuprofen, patients should seek medical advice if they have a history of serious side effects from pain relievers or fever reducers, if the stomach bleeding warning applies to them, or if they have a history of gastrointestinal issues such as heartburn. Patients with high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke should also consult a healthcare provider prior to use. Furthermore, individuals taking aspirin for cardiovascular protection should be aware that ibuprofen may diminish the effectiveness of aspirin. It is also recommended that patients under a physician's care for any serious condition or those taking other medications consult with a doctor or pharmacist before using ibuprofen.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Unishield Ibuprofen (ibuprofen). 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 patients 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. The maximum dosage should not exceed 6 tablets in a 24-hour period unless directed by a healthcare provider.

It is essential to keep this medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

Geriatric Use

Elderly patients, particularly those aged 60 years and older, are at an increased risk for severe stomach bleeding when using this medication. Therefore, it is crucial to exercise caution when prescribing to this population.

To mitigate the risk of gastrointestinal upset, it is recommended that the medication be taken with food or milk. Additionally, the smallest effective dose should be utilized to minimize potential adverse effects.

Healthcare providers should advise geriatric patients not to exceed a maximum of 6 tablets within a 24-hour period unless specifically directed by a physician. Furthermore, the duration of use should not exceed 10 days unless otherwise instructed by a healthcare professional. Regular monitoring for any signs of gastrointestinal bleeding or other adverse reactions is advised in elderly patients receiving this treatment.

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. Healthcare providers should carefully consider the potential risks and benefits when prescribing this medication to women of childbearing potential.

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 mothers.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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 overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may indicate an overdose. These may include, but are not limited to, increased severity of known side effects, unusual behavioral changes, or any other atypical clinical manifestations.

Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and symptomatic treatment should be initiated as necessary. It is recommended that healthcare professionals consult local poison control centers or relevant toxicology resources for specific guidance on the management of overdose cases.

In summary, while specific overdosage information is not available, healthcare professionals should exercise caution, remain observant for potential overdose symptoms, and implement appropriate management strategies as needed.

Nonclinical Toxicology

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

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions such as hives, skin reddening, asthma (wheezing), facial swelling, rash, shock, and blisters. Additionally, severe stomach bleeding has been noted, particularly in individuals over 60 years of age, those with a history of stomach ulcers or bleeding problems, and those concurrently using anticoagulants or other nonsteroidal anti-inflammatory drugs (NSAIDs). Furthermore, there is an increased risk of heart attack, heart failure, and stroke associated with NSAID use, especially when utilized in higher doses or for extended durations.

Patient Counseling

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

Patients should be informed not to use this medication if they have ever experienced an allergic reaction to any other pain reliever or fever reducer. Additionally, it is important to counsel patients against using this product right before or after heart surgery.

Patients should be instructed to stop using the medication and consult a doctor if they experience any signs of stomach bleeding, such as feeling faint, vomiting blood, or having bloody or black stools. They should also seek medical advice if they have stomach pain that does not improve, or if they exhibit symptoms of heart problems or stroke, including chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or leg swelling.

Healthcare providers should emphasize that patients need to stop use and consult a doctor if their pain worsens or persists for more than 10 days, if their fever worsens or lasts for more than 3 days, or if there is redness or swelling in the painful area. Patients should also be advised to seek medical attention if any new or unexpected symptoms occur.

When using this product, patients should be counseled to take it with food or milk if they experience stomach upset. It is essential for patients to ask a doctor before use if they have experienced problems or serious side effects from taking pain relievers or fever reducers in the past.

Patients should be encouraged to consult a doctor before use if the stomach bleeding warning applies to them, if they have a history of stomach problems such as heartburn, or if they have conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. Additionally, patients taking a diuretic should seek medical advice before using this medication.

Healthcare providers should also recommend that patients consult a doctor or pharmacist before using this product if they are taking aspirin for heart attack or stroke, as ibuprofen may reduce the effectiveness of aspirin. Finally, patients under a doctor's care for any serious condition or those taking any other medications should be advised to consult their healthcare provider or pharmacist prior to use.

Storage and Handling

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

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)