Kroger Extra Strength Headache Relief Geltab

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the available text.

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

Healthcare professionals should advise patients to adhere strictly to the recommended dosage and not exceed the directed amount. Each dose should be accompanied by a full glass of water to ensure proper administration.

For adults and children aged 12 years and older, the recommended dosage is 2 geltabs every 6 hours, with a maximum of 8 geltabs within a 24-hour period.

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

Contraindications

Use is contraindicated in children due to the risk of accidental ingestion. In the event of an overdose, immediate medical assistance should be sought, and contacting a Poison Control Center is essential for both adults and children, regardless of the presence of symptoms.

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.

Allergy Alerts Acetaminophen may lead to severe skin reactions, which can manifest as skin reddening, blisters, or rash. Should any skin reaction occur, the use of the product must be discontinued, and medical assistance should be sought without delay. Similarly, aspirin may provoke a severe allergic reaction characterized by hives, facial swelling, asthma (wheezing), or shock.

Liver Warning This product contains acetaminophen, and severe liver damage may occur if the maximum daily dosage of 8 geltabs is exceeded within a 24-hour period, if it is taken concurrently with other medications containing acetaminophen, or if consumed with 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 is increased in individuals aged 60 or older, those with a history of stomach ulcers or bleeding problems, users of blood thinners or steroid medications, individuals taking other NSAIDs (including aspirin, ibuprofen, or naproxen), and those consuming three or more alcoholic drinks daily while using this product. Additionally, exceeding the recommended dosage or duration of use may elevate this risk.

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

Contraindications This product should not be used by individuals with a known allergy to acetaminophen, aspirin, or any other pain reliever/fever reducer. It should also not be taken in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in a medication, consultation with a healthcare provider or pharmacist is recommended.

Consultation Required Healthcare professionals should be consulted prior to use if the patient has liver disease, if the stomach bleeding warning applies, if there is a history of stomach problems (such as heartburn), or if the patient has high blood pressure, heart disease, liver cirrhosis, or kidney disease. Additionally, individuals taking diuretics or those with asthma should seek medical advice before use. It is also important to consult a healthcare provider if the patient is taking prescription medications for diabetes, gout, or arthritis, or if they are under medical care for any serious condition.

Discontinuation of Use The product should be discontinued and medical advice sought if an allergic reaction occurs. Immediate medical attention is necessary if any signs of stomach bleeding are observed, including feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Other concerning symptoms include ringing in the ears, loss of hearing, redness or swelling in a painful area, worsening pain lasting more than 10 days, fever that worsens or lasts more than three days, or the emergence of any new symptoms, as these may indicate a serious condition.

Pregnancy and Breastfeeding Consultation with a healthcare professional is essential before using this product if pregnant or breastfeeding. Aspirin should be avoided 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.

Overdose In the event of an overdose, immediate medical assistance or contact with a Poison Control Center is crucial. Prompt medical attention is necessary for both adults and children, even if no signs or symptoms are immediately apparent.

Side Effects

Patients using this product should be aware of several potential adverse reactions, which can range from serious to common.

Serious adverse reactions include the risk of Reye’s syndrome, particularly 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 may indicate the onset of this rare but serious illness.

Allergic reactions can also occur. Acetaminophen may lead to severe skin reactions, which can manifest as skin reddening, blisters, or rash. Should any skin reaction occur, patients are advised to discontinue use and seek medical assistance promptly. Additionally, aspirin may provoke a severe allergic reaction characterized by hives, facial swelling, asthma (wheezing), or shock, necessitating immediate medical attention.

Liver damage is another serious concern associated with this product, which contains acetaminophen. Severe liver damage may occur if patients exceed the maximum daily dosage of 8 geltabs within 24 hours, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product.

The product also contains a nonsteroidal anti-inflammatory drug (NSAID), which may increase the risk of severe stomach bleeding. This risk is heightened in patients aged 60 or older, those with a history of stomach ulcers or bleeding problems, individuals taking blood thinners or steroid medications, and those consuming three or more alcoholic drinks daily while using this product. Patients should also be cautious if taking other NSAIDs, whether prescription or over-the-counter, and should not exceed the recommended duration or dosage.

Common adverse reactions may include symptoms related to caffeine intake. The recommended dose of this product contains approximately the same amount of caffeine as a cup of coffee. Patients are advised to limit the use of other caffeine-containing medications, foods, or beverages, as excessive caffeine consumption may lead to nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Patients should 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, having bloody or black stools, or persistent stomach pain), ringing in the ears or loss of hearing, redness or swelling in a painful area, worsening pain lasting more than 10 days, fever lasting more than 3 days, or any new symptoms. These may be indicative of a serious condition requiring medical evaluation.

Drug Interactions

Caution is advised when this product is used concurrently with other medications containing acetaminophen, whether prescription or nonprescription. The potential for hepatotoxicity may be increased due to cumulative acetaminophen exposure.

The concomitant use of this product with anticoagulants or steroid medications may elevate the risk of severe gastrointestinal bleeding. Clinicians should monitor patients closely for signs of gastrointestinal distress and consider dosage adjustments as necessary.

Additionally, the risk of severe stomach bleeding is heightened when this product is taken alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including but not limited to aspirin, ibuprofen, and naproxen. It is recommended that healthcare providers assess the necessity of concurrent NSAID therapy and monitor for gastrointestinal complications.

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

Packaging & NDC

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

Pediatric Use

Pediatric patients, particularly children and teenagers, should not use this product if they have or are recovering from chicken pox or flu-like symptoms due to the risk of Reye’s syndrome. Healthcare professionals are advised to consult a doctor if any changes in behavior accompanied by nausea and vomiting occur, as these may be early indicators of Reye’s syndrome.

For dosing, adults and children aged 12 years and older are instructed to take 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 recommended to consult a doctor for appropriate dosing guidance.

It is essential to keep this product 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. Prompt medical attention is critical for both adults and children, even if no signs or symptoms are initially apparent.

Geriatric Use

Elderly patients, particularly those aged 60 and older, may have an increased risk of severe stomach bleeding. Healthcare providers should exercise caution when prescribing this medication to geriatric patients, considering the potential for heightened adverse effects.

It is advisable to closely monitor elderly patients for signs of gastrointestinal bleeding and to evaluate the necessity of dosage adjustments based on individual patient factors. Careful assessment of the benefits and risks is essential in this population to ensure safe and effective use of the medication.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. The use of aspirin during the last trimester of pregnancy is particularly cautioned against, as it may lead to adverse effects on fetal development or complications during delivery. Therefore, it is essential that pregnant patients only use aspirin under the guidance of a physician if deemed necessary.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. It is particularly important to avoid the use of aspirin during the last three months of pregnancy unless explicitly 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 while breastfeeding.

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 using this product. It is important to note that this product contains acetaminophen, which carries a risk of severe liver damage. Patients with compromised liver function must be particularly cautious, as exceeding the maximum daily dosage of 8 geltabs within a 24-hour period, or concurrently using other medications containing acetaminophen, may significantly increase the risk of liver injury. Additionally, the consumption of three or more alcoholic drinks daily while using this product is contraindicated due to the potential for exacerbating liver damage. Monitoring of liver function may be warranted in patients with existing liver disease to ensure safety and prevent adverse effects.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt medical intervention is crucial for both adults and children, even in the absence of observable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, it is essential to monitor the patient closely and provide appropriate care as directed by medical guidelines.

Nonclinical Toxicology

It is especially important not to use aspirin 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 additional non-teratogenic effects or specific nonclinical toxicology details have been identified in the available 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 to keep the medication out of reach of children to prevent accidental ingestion. It is essential to emphasize the importance of seeking immediate medical assistance or contacting a Poison Control Center in the event of an overdose. Patients should be informed that prompt medical attention is critical for both adults and children, even if they do not exhibit any signs or symptoms of overdose.

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 room temperature, maintaining a range of 20°-25°C (68°-77°F). Proper storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered orally, with specific dosing guidelines for different age groups. Adults and children aged 12 years and older are instructed to take 2 geltabs every 6 hours, not exceeding 8 geltabs within a 24-hour period. For children under 12 years of age, it is recommended to consult a doctor for appropriate dosing.

Clinicians should counsel patients on important safety information. Pregnant or breastfeeding individuals should seek advice from a health professional before use, particularly noting that aspirin should generally be avoided during the last trimester of pregnancy unless specifically directed by a physician due to potential risks to the unborn child or complications during delivery. Additionally, it is crucial to keep the medication out of reach of children and to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose, as prompt attention is vital for both adults and children, regardless of the presence of symptoms.

Drug Information (PDF)

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

View product document (PDF)