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Drx Choice

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Active ingredients
  • Acetaminophen 500 mg
  • Caffeine 65 mg
Other brand names
Drug classes
Central Nervous System Stimulant, Methylxanthine
Dosage form
Tablet, Film Coated
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2025
Label revision date
June 13, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Acetaminophen 500 mg
  • Caffeine 65 mg
Other brand names
Drug classes
Central Nervous System Stimulant, Methylxanthine
Dosage form
Tablet, Film Coated
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2025
Label revision date
June 13, 2025
Manufacturer
Raritan Pharmaceuticals Inc.
Registration number
M013
NDC root
68163-506
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

DRx Choice Tension Headache Relief is a medication designed to temporarily relieve minor aches and pains associated with headaches and muscular discomfort. It contains two active ingredients: acetaminophen (a common pain reliever) at 500 mg and caffeine at 65 mg, and it is formulated without aspirin.

This product acts as a pain reliever and is comparable to Excedrin® Tension Headache, providing you with an option to help alleviate tension headaches effectively.

Uses

You can use this medication to temporarily relieve minor aches and pains, such as headaches and muscular aches. It’s designed to help you feel more comfortable when you're experiencing these common discomforts.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication, making it a safer option for those who may be concerned about such risks.

Dosage and Administration

It's important to follow the dosage instructions carefully to ensure your safety and effectiveness of the medication. If you are an adult or a child aged 12 years and older, you should take 2 caplets by mouth every 6 hours. However, make sure not to exceed 6 caplets in a 24-hour period.

For children under 12 years of age, it's best to consult a doctor before giving them this medication. Always remember to take the caplets as directed and never use more than the recommended amount.

What to Avoid

You should avoid using this medication if you are allergic to acetaminophen, as it can cause serious reactions. Additionally, do not take it alongside any other medications that contain acetaminophen, whether they are prescription or over-the-counter. If you're unsure whether a medication contains acetaminophen, it's important to consult with your doctor or pharmacist for guidance. Taking these precautions will help ensure your safety while using this medication.

Side Effects

You should be aware that acetaminophen can cause severe skin reactions, which may include symptoms like skin reddening, blisters, or rash. If you experience any of these reactions, stop using the product immediately and seek medical help. Additionally, taking more than six caplets in 24 hours, using other medications that contain acetaminophen, or consuming three or more alcoholic drinks daily while using this product can lead to severe liver damage.

It's also important to note that the recommended dose of this product contains about as much caffeine as a cup of coffee. Be cautious with other caffeine sources, as too much can lead to nervousness, irritability, sleeplessness, and sometimes a rapid heartbeat. If you have liver disease or are taking the blood-thinning medication warfarin, consult your doctor before using this product. Stop using it and contact a doctor if you notice any new symptoms, if a painful area becomes red or swollen, if pain lasts more than 10 days, or if a fever worsens or lasts more than three days, as these could indicate a serious condition.

Warnings and Precautions

You should be aware of some important warnings and precautions when using this product. First, if you notice any severe skin reactions such as reddening, blisters, or a rash, stop using the product immediately and seek medical help. Additionally, be cautious with the amount you take; exceeding 6 caplets in 24 hours, using other medications that contain acetaminophen, or consuming 3 or more alcoholic drinks daily while using this product can lead to severe liver damage.

If you have liver disease or are taking the blood-thinning medication warfarin, consult your doctor before using this product. It's also important to limit your intake of caffeine from other sources, as too much can lead to nervousness, irritability, and sleeplessness. In case of an overdose, seek emergency medical help or contact a Poison Control Center at 1-800-222-1222 right away, even if you don't notice any symptoms.

Finally, stop using the product and call your doctor if you experience any new symptoms, if a painful area becomes red or swollen, if your pain worsens or lasts more than 10 days, or if your fever gets worse or lasts more than 3 days, as these could indicate a serious condition.

Overdose

If you suspect an overdose, it’s important to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance. Quick action is crucial for both adults and children, even if you don’t see any signs or symptoms of an overdose.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t hesitate to get help right away. Remember, it’s always better to be safe and seek assistance if you have any concerns about an overdose.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

If you are considering this medication for your child, it's important to know that children under 12 years old should consult a doctor before use. For those aged 12 and older, the recommended dosage is 2 caplets every 6 hours, but do not exceed 6 caplets in a 24-hour period. Always follow these guidelines to ensure safe and effective use.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication may affect you if your kidneys are not functioning properly.

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can help monitor your condition and make any necessary adjustments to your treatment plan.

Hepatic Impairment

If you have liver problems, it's important to be cautious when using this product, which contains acetaminophen. To avoid severe liver damage, do not exceed 6 caplets in a 24-hour period, and be careful not to take other medications that also contain acetaminophen. Additionally, limit your alcohol intake to fewer than 3 drinks per day while using this product, as drinking more can increase the risk of liver damage.

Before using this product, please consult your doctor if you have liver disease. They can provide guidance tailored to your specific health needs and help ensure your safety while using this medication.

Drug Interactions

It's important to talk to your doctor or pharmacist before using this product, especially if you are taking the blood thinner warfarin, as it can affect how your medications work together. Additionally, be cautious with caffeine—try to limit your intake of caffeine-containing foods, drinks, or medications while using this product, as too much caffeine can lead to feelings of nervousness, irritability, sleeplessness, and even a rapid heartbeat.

You should also avoid using this product alongside any other medications that contain acetaminophen, whether they are prescription or over-the-counter. If you're unsure whether a medication contains acetaminophen, don't hesitate to ask your healthcare provider for guidance. Always prioritize open communication with your healthcare team to ensure your safety and well-being.

Storage and Handling

To ensure the best performance of your product, store it at room temperature. This helps maintain its effectiveness and safety. After each use, make sure to close the cap tightly to prevent contamination and preserve the integrity of the contents. Following these simple steps will help you use the product safely and effectively.

Additional Information

You should take this medication orally. For adults and children aged 12 years and older, the recommended dose is 2 caplets every 6 hours, with a maximum of 6 caplets in a 24-hour period. If the patient is under 12 years old, consult a doctor for the appropriate dosage.

If you are pregnant or breastfeeding, it's important to talk to a healthcare professional before using this medication. In the event of an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Quick medical attention is crucial for both adults and children, even if there are no noticeable symptoms.

FAQ

What is DRx Choice Tension Headache Relief used for?

DRx Choice Tension Headache Relief temporarily relieves minor aches and pain due to headaches and muscular aches.

What are the active ingredients in DRx Choice Tension Headache Relief?

The active ingredients are Acetaminophen 500 mg and Caffeine 65 mg.

How should I take DRx Choice Tension Headache Relief?

Adults and children 12 years and over should take 2 caplets every 6 hours, not exceeding 6 caplets in 24 hours. For children under 12 years, consult a doctor.

Are there any contraindications for using this product?

Do not use if you are allergic to acetaminophen or with any other drug containing acetaminophen. If unsure, ask a doctor or pharmacist.

What should I do if I experience a skin reaction?

If you notice symptoms like skin reddening, blisters, or rash, stop use and seek medical help immediately.

What are the liver warnings associated with this product?

Severe liver damage may occur if you take more than 6 caplets in 24 hours, use with other acetaminophen-containing drugs, or consume 3 or more alcoholic drinks daily while using this product.

Can I use caffeine-containing products while taking this medication?

Limit the use of caffeine-containing medications, foods, or beverages, as too much caffeine may cause nervousness, irritability, sleeplessness, and rapid heartbeat.

What should I do in case of an overdose?

In case of overdose, get medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Is it safe to use DRx Choice Tension Headache Relief during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, consult a health professional before use.

Where should I store DRx Choice Tension Headache Relief?

Store at room temperature and close the cap tightly after use.

Packaging Info

Below are the non-prescription pack sizes of Drx Choice (acetaminophen, caffeine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Drx Choice.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

DRx Choice tension headache relief contains active ingredients of Acetaminophen (500 mg) and Caffeine (65 mg). This formulation is aspirin-free and is classified as a pain reliever and pain reliever aid. The product is packaged in a size of 15 caplets and features tamper-evident packaging, with a warning to not use if the printed inner seal under the cap is broken or missing.

This product is distributed by Raritan Pharmaceuticals, located at 8 Joanna Court, East Brunswick, NJ 08816. The National Drug Code (NDC) for this product is 68163-506-15. It is comparable to the active ingredients found in Excedrin® Tension Headache.

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 taken orally 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.

Administration should be performed orally, ensuring that the caplets are taken as directed.

Contraindications

Use of this product is contraindicated in patients with a known allergy to acetaminophen. Additionally, it should not be used concurrently with any other medications that contain acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

Warnings and Precautions

Acetaminophen may cause severe skin reactions, including symptoms such as skin reddening, blisters, and rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding the maximum daily dosage of 6 caplets within a 24-hour period, concurrent use with other medications containing acetaminophen, or consumption of 3 or more alcoholic drinks daily while using this product.

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. Healthcare professionals should advise patients to limit the use of other caffeine-containing medications, foods, or beverages during treatment, as excessive caffeine consumption may lead to symptoms such as nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Before initiating treatment, patients should consult a healthcare provider if they have a history of liver disease. Additionally, it is recommended that patients taking the anticoagulant warfarin seek guidance from a doctor or pharmacist prior to use.

In the case of an overdose, immediate medical attention is crucial. Patients should contact a Poison Control Center at 1-800-222-1222 without delay, as prompt intervention is essential for both adults and children, even in the absence of noticeable symptoms.

Patients are advised to discontinue use and consult a healthcare professional if any new symptoms arise, if the painful area becomes red or swollen, if pain worsens or persists beyond 10 days, or if fever intensifies or lasts longer than 3 days. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Patients may experience a range of adverse reactions while using this product. Serious adverse reactions include severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. In the event of a skin reaction, patients are advised to discontinue use immediately and seek medical assistance.

There is a significant risk of severe liver damage if the product is used improperly. This risk is heightened if patients exceed the maximum daily dosage of 6 caplets within a 24-hour period, use other medications containing acetaminophen concurrently, or consume 3 or more alcoholic drinks daily while using this product. Patients with pre-existing liver disease should consult a healthcare professional before use.

Caffeine is also a consideration, as the recommended dose 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 to avoid potential side effects such as nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Patients should refrain from using this product if they are allergic to acetaminophen or if they are taking any other medications that contain acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, patients should consult a doctor or pharmacist.

Patients are encouraged to seek medical advice if any new symptoms arise, if a 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. Additionally, patients taking the blood-thinning medication warfarin should consult a healthcare professional before using this product.

Drug Interactions

Patients should consult a healthcare professional prior to using this product if they are concurrently taking warfarin, a blood-thinning medication. The combination may necessitate careful monitoring due to potential interactions that could affect anticoagulation levels.

Caution is advised regarding the consumption of caffeine-containing medications, foods, or beverages while using this product. Excessive caffeine intake may lead to adverse effects such as nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat. Patients should limit their caffeine consumption to mitigate these risks.

This product should not be used in conjunction with any other medications that contain acetaminophen, whether prescription or over-the-counter. Patients uncertain about the acetaminophen content in their medications are encouraged to seek guidance from a healthcare professional to avoid unintentional overdose.

Packaging & NDC

Below are the non-prescription pack sizes of Drx Choice (acetaminophen, caffeine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Drx Choice.
Details

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

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in 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 considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on the excretion of this drug in human 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 patients with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients, although specific recommendations are not provided.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, which contains acetaminophen. Severe liver damage may occur if patients exceed the maximum daily dosage of 6 caplets within a 24-hour period. Additionally, patients should avoid concomitant use with other medications containing acetaminophen, as this may further increase the risk of liver injury.

It is also advised that patients with compromised liver function refrain from consuming 3 or more alcoholic drinks daily while using this product, as this can exacerbate the potential for liver damage.

Before initiating treatment, patients with liver disease should consult a healthcare professional to assess the appropriateness of this product for their condition. Regular monitoring of liver function may be warranted in these patients to ensure safety and efficacy.

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 medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the timely recognition and management of overdose situations can significantly impact patient outcomes. Therefore, it is essential to remain vigilant and proactive in addressing potential overdose cases.

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 limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Patients should be advised to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is crucial to obtain prompt medical attention for both adults and children, even if no signs or symptoms are apparent.

Patients should be informed not to use this medication if they have a known allergy to acetaminophen. Additionally, they should be cautioned against using this product in conjunction with any other medications that contain acetaminophen, whether prescription or nonprescription. If patients are uncertain about the contents of a medication, they should consult a healthcare professional, such as a doctor or pharmacist.

Patients should be instructed to discontinue use and consult a doctor if they experience any new symptoms. They should also stop using the medication and seek medical advice if the area of pain becomes red or swollen, if the pain worsens or persists for more than 10 days, or if a fever intensifies or lasts longer than 3 days, as these may indicate a serious condition.

Furthermore, patients should be encouraged to consult a doctor prior to using this medication if they have a history of liver disease. It is also advisable for patients to speak with a healthcare professional before use if they are currently taking the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at room temperature to maintain its efficacy. After each use, it is essential to close the cap tightly to ensure the integrity of the product and prevent contamination.

Additional Clinical Information

The medication is administered orally. For adults and children 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. For children under 12 years, it is advised to consult a doctor for appropriate dosing.

Patients should be counseled to seek advice from a healthcare professional if they are pregnant or breastfeeding. In the event of an overdose, it is crucial to obtain medical assistance or contact a Poison Control Center immediately at 1-800-222-1222, as prompt medical attention is essential for both adults and children, regardless of the presence of symptoms.

Drug Information (PDF)

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

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Drx Choice, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

Last AI update:

Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.