Dg Health Headache Relief

Description

Acetaminophen, Aspirin (NSAID), and Caffeine are the active ingredients in this formulation, designed as a pain reliever and pain reliever aid. The product is presented in the form of 80 Geltabs, each of which is formulated to provide effective relief from pain. The actual size of the Geltabs is consistent with standard dosage forms for ease of administration.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, cold symptoms, arthritis, muscular aches, toothache, and premenstrual or menstrual cramps.

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

Dosage and Administration

Patients should adhere strictly to the recommended dosage. For adults and children aged 12 years and older, the prescribed dosage is 2 geltabs every 6 hours, with a maximum of 8 geltabs within a 24-hour period. It is essential to consume a full glass of water with each dose to ensure proper administration and absorption.

For children under 12 years of age, it is advised to consult a physician for appropriate dosing recommendations.

Contraindications

Use is contraindicated in patients with a history of allergic reactions to acetaminophen, aspirin, or any other pain reliever or fever reducer. Additionally, concurrent use with any other medication containing acetaminophen, whether prescription or nonprescription, is contraindicated. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

Warnings and Precautions

Children and teenagers who are experiencing or recovering from chickenpox or flu-like symptoms should not use this product due to the risk of Reye’s syndrome, a rare but serious illness. If any changes in behavior accompanied by nausea and vomiting occur while using this product, it is imperative to consult a healthcare professional immediately, as these may be early indicators of Reye’s syndrome.

Allergy Alerts

Acetaminophen, a component of this product, has been associated with severe skin reactions. Symptoms may include skin reddening, blisters, and rash. Should any skin reaction occur, the use of this product must be discontinued, and medical assistance should be sought without delay.

Aspirin may also provoke severe allergic reactions, which can manifest as hives, facial swelling, asthma (wheezing), or shock. Immediate medical attention is warranted if any of these symptoms arise.

Liver Warning

This product contains acetaminophen, and severe liver damage may occur if the following conditions are met: exceeding 4,000 mg of acetaminophen within a 24-hour period, concurrent use with other medications containing acetaminophen, or consumption of three or more alcoholic drinks daily while using this product.

Stomach Bleeding Warning

As this product contains a nonsteroidal anti-inflammatory drug (NSAID), there is a risk of severe stomach bleeding. The likelihood of this adverse effect increases in individuals who are 60 years of age or older, have a history of stomach ulcers or bleeding problems, are taking anticoagulants or steroid medications, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic drinks daily, or exceed the recommended dosage or duration of use.

Caffeine Warning

The recommended dosage of this product contains approximately the same amount of caffeine as a standard cup of coffee. It is advisable to limit the intake of other caffeine-containing medications, foods, or beverages while using this product, as excessive caffeine consumption may lead to nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Emergency Medical Help

In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms are initially apparent.

Discontinuation of Use

Healthcare professionals should advise patients to stop using this product and seek medical advice if any of the following occur: signs of an allergic reaction, symptoms indicative of stomach bleeding (such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain), tinnitus or hearing loss, redness or swelling in a painful area, worsening pain lasting more than 10 days, fever that worsens or persists for more than three days, or the emergence of any new symptoms. These may signify a serious condition requiring further evaluation.

Side Effects

Patients using this product should be aware of several serious adverse reactions and warnings associated with its use.

Reye’s syndrome is a rare but serious illness that may occur in children and teenagers who have or are recovering from chickenpox or flu-like symptoms. If patients experience changes in behavior accompanied by nausea and vomiting while using this product, they should consult a doctor immediately, as these symptoms could indicate the onset of Reye’s syndrome.

Severe skin reactions have been reported in patients allergic to acetaminophen, with symptoms including skin reddening, blisters, and rash. In the event of a skin reaction, patients are advised to discontinue use and seek medical assistance promptly. Similarly, aspirin may provoke severe allergic reactions, which can manifest as hives, facial swelling, asthma (wheezing), or shock. Immediate medical attention is warranted if any of these symptoms occur.

The product contains acetaminophen, which poses a risk of severe liver damage if patients exceed 4,000 mg in 24 hours, use it in conjunction with other acetaminophen-containing medications, or consume three or more alcoholic drinks daily while using the product.

Additionally, the presence of a nonsteroidal anti-inflammatory drug (NSAID) in this product raises the risk of severe stomach bleeding, particularly in patients aged 60 or older, those with a history of stomach ulcers or bleeding problems, and individuals taking anticoagulants, steroids, or other NSAIDs. Patients should be cautious if they consume three or more alcoholic drinks daily or take the medication for longer than directed.

Caffeine is also a component of the recommended dose, which is comparable to that found in a cup of coffee. Patients should limit the intake of other caffeine-containing products to avoid potential side effects such as nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Patients are advised to stop using the product and consult a doctor if they experience any signs of an allergic reaction, symptoms indicative of stomach bleeding (such as feeling faint, vomiting blood, or having bloody or black stools), or if they develop new symptoms that could suggest a serious condition.

Before using this product, patients should seek medical advice if they have liver disease, a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, kidney disease, or if they are taking diuretics or have asthma. Furthermore, patients taking prescription medications for diabetes, gout, or arthritis, or any other serious condition, should consult a doctor or pharmacist prior to use.

Drug Interactions

Patients should consult a healthcare professional prior to using this product if they are concurrently taking any of the following:

Anticoagulants and Steroids The use of blood-thinning medications (anticoagulants) or steroid drugs may increase the risk of adverse effects. Monitoring for signs of bleeding or other complications is advised.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) Concurrent use with other NSAIDs, including prescription or nonprescription options such as aspirin, ibuprofen, or naproxen, may elevate the risk of gastrointestinal bleeding or other side effects. Caution is recommended, and dosage adjustments may be necessary.

Diabetes, Gout, or Arthritis Medications Patients on prescription medications for diabetes, gout, or arthritis should seek medical advice before use, as interactions may alter the effectiveness of these treatments or exacerbate underlying conditions.

Caffeine-Containing Products The intake of caffeine-containing medications, foods, or beverages should be limited while using this product. Excessive caffeine consumption may lead to symptoms such as nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Acetaminophen This product should not be used in conjunction with other medications containing acetaminophen, whether prescription or nonprescription. Patients uncertain about the presence of acetaminophen in their medications should consult a healthcare professional.

Liver Disease and Other Serious Conditions Individuals with liver disease, a history of stomach problems (such as heartburn), high blood pressure, heart disease, liver cirrhosis, kidney disease, or those taking diuretics should seek medical advice before using this product. The potential for serious side effects, including stomach bleeding, necessitates careful monitoring and possible dosage adjustments.

Packaging & NDC

Below are the non-prescription pack sizes of Dg Health Headache Relief (acetaminophen, aspirin, caffeine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product due to the risk of Reye’s syndrome, a rare but serious illness. If changes in behavior accompanied by nausea and vomiting occur while using this product, it is important to consult a doctor, as these may be early signs of Reye’s syndrome.

For children under 12 years of age, it is advised to consult a doctor before use. For adults and children aged 12 years and older, the recommended dosage is 2 geltabs every 6 hours, with a maximum of 8 geltabs in a 24-hour period.

In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222. Quick medical attention is critical for both adults and children, even if no signs or symptoms are apparent.

Geriatric Use

Elderly patients, specifically those aged 60 years and older, are advised to consult a healthcare provider prior to using this medication. This precaution is essential to ensure the safe and effective use of the treatment in this age group, as geriatric patients may have different physiological responses and potential risks associated with medication use. Careful consideration and monitoring are recommended to address any age-related factors that may influence the medication's efficacy and safety profile.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. The use of aspirin during pregnancy, particularly at 20 weeks gestation or later, is associated with potential risks. Specifically, it may lead to adverse effects on fetal development and complications during delivery. Therefore, aspirin should only be used in this period if explicitly directed by a healthcare provider. Caution is advised to ensure the safety of both the mother and the unborn child.

Lactation

Lactating mothers are advised to consult a health professional before using this medication. It is particularly important to avoid the use of aspirin at 20 weeks of pregnancy or later 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 available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering the use of this medication during lactation.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have underlying 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 using this product. It is important to note that this product contains acetaminophen, which carries a risk of severe liver damage under certain conditions. Specifically, patients with compromised liver function should be aware that exceeding 4,000 mg of acetaminophen within a 24-hour period may lead to significant hepatic injury.

Additionally, concurrent use of other medications containing acetaminophen should be avoided to prevent cumulative dosing that could exacerbate the risk of liver damage. Patients are also advised against consuming three or more alcoholic beverages daily while using this product, as this may further increase the likelihood of severe liver complications.

Monitoring of liver function may be warranted in patients with existing liver disease or those who are at risk for hepatic impairment. It is essential for these patients to adhere to the recommended guidelines to mitigate the risk of adverse effects related to liver health.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt intervention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, vigilance and timely action are crucial in managing overdose situations effectively.

Nonclinical Toxicology

It is especially important not to use aspirin at 20 weeks or later in pregnancy unless definitely 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 or additional nonclinical toxicology details are available in the provided data. Furthermore, there are no specific findings related to animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients on the importance of seeking immediate medical assistance in the event of an overdose. Patients should be informed to contact a Poison Control Center at 1-800-222-1222 without delay. It is crucial to emphasize that prompt medical attention is necessary for both adults and children, even if they do not exhibit any signs or symptoms of overdose. This information is vital for ensuring patient safety and effective management of potential overdose situations.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at a controlled temperature range of 20° to 25°C (68° to 77°F) to maintain its efficacy and safety.

After each use, the cap must be closed tightly to prevent contamination and ensure the integrity of the product. Users are advised to read all product information thoroughly before use and to retain the packaging for future reference, as it contains important information regarding the product.

Additional Clinical Information

The route of administration for the medication is oral. For adults and children aged 12 years and older, the recommended dosage is 2 geltabs every 6 hours, with a maximum of 8 geltabs in a 24-hour period. For children under 12 years of age, it is advised to consult a doctor for appropriate dosing.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding, as the use of aspirin after 20 weeks of pregnancy may pose risks to the unborn child or lead to complications during delivery. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222, as prompt attention is crucial for both adults and children, regardless of the presence of symptoms.

Drug Information (PDF)

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

View product document (PDF)