Help I Have an Aching Body

Description

No relevant information is available for SPL code 34089-3.

Uses and Indications

This drug is indicated for use in patients as determined by the prescribing healthcare professional. Currently, there are no specific indications or usage details provided.

There are no known teratogenic or nonteratogenic effects associated with this drug. Healthcare professionals should consider the absence of these effects when evaluating treatment options for their patients.

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. However, it is imperative not to exceed 6 tablets within a 24-hour period unless specifically directed by a healthcare professional.

For children under 12 years of age, consultation with a doctor is recommended prior to administration. It is essential to adhere to the prescribed dosage and not to exceed the directed amount. The smallest effective dose should always be utilized to minimize potential risks.

To mitigate the risk of stomach upset, it is recommended that the tablets be taken with food or milk.

Contraindications

Use is contraindicated in individuals 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

Patients should be informed of the potential for severe allergic reactions associated with ibuprofen, particularly in individuals with a known allergy to aspirin. Symptoms indicative of an allergic reaction may include shock, hives, facial swelling, asthma (wheezing), rash, skin reddening, and blisters. In the event of an allergic reaction, it is imperative to discontinue use immediately and seek medical assistance.

The use of ibuprofen carries a risk of stomach bleeding, a serious side effect associated with nonsteroidal anti-inflammatory drugs (NSAIDs). The likelihood of experiencing stomach bleeding is increased in patients who meet any of the following criteria: individuals aged 60 years or older, those with a history of stomach ulcers or bleeding disorders, patients concurrently using blood thinners (anticoagulants) or steroid medications, individuals taking other NSAIDs (such as aspirin, ibuprofen, or naproxen), those consuming three or more alcoholic beverages daily while using this product, or patients exceeding 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 symptoms: feeling faint, vomiting blood, or passing bloody or black stools, which may indicate stomach bleeding; worsening pain or pain persisting beyond 10 days; fever that worsens or lasts more than 3 days; worsening stomach pain or upset lasting more than 10 days; redness or swelling in the affected area; or the emergence of any new symptoms.

Prior to initiating treatment with ibuprofen, patients should be encouraged to consult a healthcare provider if they have a history of adverse reactions to pain relievers or fever reducers, ongoing stomach issues such as heartburn or stomach pain, bleeding disorders, ulcers, high blood pressure, prior use of diuretics, or pre-existing heart or kidney conditions. Special consideration should be given to patients aged 60 years or older.

Additionally, patients should seek guidance from a healthcare professional or pharmacist before using ibuprofen if they are currently taking any other NSAIDs (whether prescription or over-the-counter), blood thinners (anticoagulants), steroid medications, or any other drugs, or if they are under medical supervision for any serious health condition.

Side Effects

Patients may experience a range of adverse reactions associated with the use of ibuprofen, which can be categorized by seriousness and frequency.

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

Another serious concern is the potential for stomach bleeding, a risk associated with the use of nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen. The likelihood of experiencing stomach bleeding is heightened in patients who are aged 60 or older, have a history of stomach ulcers or bleeding issues, 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 feeling faint, vomiting blood, or passing bloody or black stools.

Common adverse reactions may include gastrointestinal discomfort, such as stomach pain or upset, which can worsen or persist beyond 10 days. Patients should also be vigilant for any new symptoms that arise during treatment. It is recommended that patients consult a healthcare professional prior to using ibuprofen if they have a history of serious side effects from pain relievers or fever reducers, ongoing stomach issues, bleeding disorders, ulcers, high blood pressure, or heart or kidney disease, particularly if they are 60 years of age or older.

Additionally, patients should seek medical advice before using ibuprofen if they are currently taking other NSAIDs, anticoagulants, or steroid medications, or if they are under a physician's care for any serious medical condition.

Drug Interactions

Ibuprofen has the potential to induce severe allergic reactions, particularly in individuals with a known allergy to aspirin.

When considering the concomitant use of ibuprofen with anticoagulants or steroid medications, it is important to note that the risk of gastrointestinal bleeding may be significantly increased. Therefore, healthcare professionals should exercise caution and consider monitoring patients closely for signs of bleeding when these medications are used together.

Additionally, patients are advised to consult with a healthcare provider or pharmacist prior to using ibuprofen if they are currently taking any other nonsteroidal anti-inflammatory drugs (NSAIDs), whether prescription or over-the-counter. This precaution is essential to avoid potential additive effects and complications associated with NSAID use.

Packaging & NDC

Below are the non-prescription pack sizes of Help I Have an Aching Body (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 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 in a 24-hour period unless directed by a healthcare provider. The smallest effective dose should always be utilized to minimize potential risks.

Geriatric Use

Elderly patients, particularly those aged 60 years and older, may have an increased risk of stomach bleeding. It is advisable for these patients to consult a healthcare provider prior to using this medication. Given the heightened risk associated with this age group, careful consideration and monitoring are recommended to ensure safety and efficacy in 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.

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 doctor, as it may pose risks to the unborn child or lead to complications during delivery. There is no specific data available 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 should consult a healthcare professional prior to use, particularly if they have a history of heart or kidney disease. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the degree of impairment.

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

Overdosage of ibuprofen can result in significant health risks. Healthcare professionals should be aware of the potential symptoms and management strategies associated with an overdose.

Symptoms of Overdose Patients experiencing an ibuprofen overdose may present with a range of symptoms, including nausea, vomiting, stomach pain, drowsiness, headache, and confusion. In more severe cases, the consequences can escalate to kidney failure, liver damage, or gastrointestinal bleeding.

Recommended Actions In the event of a suspected 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 treatment 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 product. Notable gastrointestinal events, including gastrointestinal bleeding, have been reported. Additionally, renal impairment and cardiovascular events have been documented in the postmarketing surveillance.

Serious skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have also been reported. Cases of liver enzyme elevations and instances of liver failure have been noted in the postmarketing data.

Furthermore, anaphylactic reactions, including shock, have been observed in patients with a history of allergic reactions to nonsteroidal anti-inflammatory drugs (NSAIDs). Reports of asthma exacerbation have been received from patients with a history of asthma or allergic reactions.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. It is crucial to emphasize the importance of safety in the home environment, particularly for households with young children.

In the event of an overdose, healthcare providers should instruct patients to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Patients should be made aware of the potential seriousness of an overdose and the need for prompt action.

Storage and Handling

The product is supplied in packaging that must be kept intact, as it contains essential information. It should be stored at a controlled room temperature between 15-30°C (59-86°F). Care should be taken to avoid exposure to excessive heat and humidity, which may compromise the integrity of the product. Additionally, the product should not be used if the packet is torn, cut, or opened, ensuring that only intact packages are utilized for safety and efficacy.

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 important to avoid ibuprofen during the last trimester of pregnancy unless specifically directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery. Patients experiencing stomach upset are recommended to take the medication with food or milk.

Drug Information (PDF)

This file contains official product information for Help I Have an Aching Body, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)