Tension Headache

Description

NDC 11822-0428-2. This product is formulated to provide relief from tension headaches and contains acetaminophen and caffeine as active ingredients. It is aspirin-free and is presented in the form of 100 coated caplets. The product is tamper evident; do not use if the imprinted safety seal under the cap is broken or missing. This formulation is not manufactured or distributed by GSK Consumer Healthcare S.A., the owner of the registered trademark Excedrin® Tension Headache. Distributed by Rite Aid, 200 Newberry Commons, Etters, PA 17319. For more information, visit www.riteaid.com.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with headache and muscular aches.

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 caplets every 6 hours, with a maximum limit of 6 caplets within a 24-hour period.

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

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, is prohibited due to the risk of acetaminophen overdose. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

• This product should not be used in individuals with a known allergy to acetaminophen, as this may lead to severe allergic reactions.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients to avoid exceeding 4,000 mg of acetaminophen within a 24-hour period, to refrain from using other medications that also contain acetaminophen, and to limit alcohol consumption to fewer than three drinks per day while using this product.

Acetaminophen may also lead to severe skin reactions, which can manifest as blisters, rash, or skin reddening. In the event of any skin reaction, patients should be instructed to discontinue use immediately and seek medical assistance.

Caution is advised regarding caffeine intake, as the recommended dose of this product contains approximately the same amount of caffeine as a standard cup of coffee. Patients should be counseled to limit the consumption of other caffeine-containing medications, foods, or beverages, as excessive caffeine intake may result in symptoms such as nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Patients with a history of liver disease should consult a healthcare provider prior to using this product. Additionally, those taking the anticoagulant warfarin should seek advice from a doctor or pharmacist before use to avoid potential interactions.

In the case of an accidental overdose, it is imperative to obtain emergency medical help or contact a Poison Control Center immediately, as prompt medical attention is crucial for both adults and children, even in the absence of noticeable symptoms.

Patients should be advised to discontinue use and consult a healthcare professional if new symptoms arise, if the painful area becomes red or swollen, if pain worsens or persists for more than 10 days, or if fever intensifies or lasts longer than 3 days, as these may indicate a serious underlying condition.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed 4,000 mg in 24 hours, use it in conjunction with other drugs containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen, which may manifest as blisters, rash, or skin reddening. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

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

Patients should not use this product in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Those with known allergies to acetaminophen should also refrain from using this product.

Before using this product, patients with liver disease should consult a healthcare professional. Additionally, individuals taking the blood-thinning medication warfarin should seek advice from a doctor or pharmacist prior to use.

Patients are advised to stop using the product and consult a doctor if new symptoms arise, if the painful area becomes red or swollen, if pain worsens or persists for more than 10 days, or if fever intensifies or lasts for more than 3 days, as these may indicate a serious condition.

In cases of accidental overdose, it is crucial for patients to seek medical help or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Drug Interactions

Concurrent use of this product with any other medications containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose and potential hepatotoxicity.

Patients taking the anticoagulant warfarin should consult a healthcare professional, such as a doctor or pharmacist, prior to using this product. The combination may necessitate careful monitoring of coagulation parameters to avoid potential alterations in anticoagulant efficacy.

Additionally, it is advisable to limit the intake of caffeine-containing medications, foods, or beverages while using this product. Excessive caffeine consumption may lead to adverse effects, including nervousness, irritability, insomnia, and, in some cases, tachycardia. Monitoring for these symptoms is recommended to ensure patient safety and comfort.

Packaging & NDC

Below are the non-prescription pack sizes of Tension Headache (acetaminophen, caffeine). 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 2 caplets every 6 hours, with a maximum of 6 caplets in a 24-hour period.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. 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 administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical for patients to adhere to the following guidelines to minimize the risk of hepatotoxicity:

• Patients should not exceed a maximum dosage of 4,000 mg of acetaminophen within a 24-hour period.

• Concurrent use with other medications containing acetaminophen is contraindicated, as this may lead to unintentional overdose and increased risk of liver damage.

• Consumption of three or more alcoholic drinks daily while using this product is not recommended, as it may exacerbate the risk of liver injury.

Additionally, patients with known liver disease are advised to consult a healthcare professional prior to using this product to ensure safe and appropriate use. Regular monitoring of liver function may be warranted in patients with compromised liver function to detect any potential adverse effects promptly.

Overdosage

In the event of an accidental overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt medical attention is crucial for both adults and children, regardless of whether any signs or symptoms are apparent.

Healthcare professionals should be aware that the absence of symptoms does not preclude the possibility of serious complications. Therefore, it is essential to monitor the patient closely and provide appropriate interventions as necessary.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data in these areas limits the understanding of the compound's potential effects in nonclinical settings.

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 accidental overdose. Patients should be informed to contact a Poison Control Center or seek medical help right away, as prompt medical attention is critical for both adults and children. It is essential to emphasize that even if no signs or symptoms are apparent, medical evaluation is necessary to ensure safety and appropriate care.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which can be found on the packaging. It is essential to store the product at a controlled room temperature of 25ºC (77ºF). Temporary excursions are permissible within the range of 15ºC to 30ºC (59ºF to 86ºF).

For proper inventory management, healthcare professionals should refer to the end flap of the packaging for the expiration date and lot number, ensuring that the product is used within its designated timeframe.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is essential to keep the medication out of reach of children. In the event of an accidental overdose, patients should seek medical assistance or contact a Poison Control Center immediately, as prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Drug Information (PDF)

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

View product document (PDF)