Drugplain

DRX CHOICE Tension Headache 500 mg/1

Acetaminophen, Caffeine · TABLET, FILM COATED · Raritan Pharmaceuticals Inc.

No Recall HistoryCurrently in Shortage
Plain English

Drx Choice Tension Headache is an over-the-counter tablet containing acetaminophen and caffeine used to relieve tension headaches. Acetaminophen reduces pain and fever while caffeine is a stimulant that can enhance the pain-relieving effects.

Key Facts

Brand Name
DRX CHOICE Tension Headache
Generic Name
Acetaminophen, Caffeine
NDC Code (Product)
68163-506
Manufacturer
Raritan Pharmaceuticals Inc.
Strength
500 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
M013
Drug Class
Central Nervous System Stimulant [EPC]; Methylxanthine [EPC]
Marketing Start
05/16/2025

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

balance disorder2 reports
blood calcium decreased2 reports
cognitive disorder2 reports
constipation2 reports
creatinine renal clearance decreased2 reports
depressed level of consciousness2 reports
fall2 reports
hypotension2 reports
mobility decreased2 reports
orthostatic hypotension2 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses temporarily relieves minor aches and pain due to: headache muscular aches

Dosage & Administration

Directions do not use more than directed adults and children 12 years and over : take 2 caplets every 6 hours; not more than 6 caplets in 24 hours children under 12 years : ask a doctor

Warnings

Warnings Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away. Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 6 caplets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally, rapid heartbeat. Do not use if you are allergic to acetaminophen with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. Ask a doctor before use if you have liver disease Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin Stop use and ask a doctor if any new symptoms occur painful area is red o…

Frequently Asked Questions

What is DRX CHOICE Tension Headache used for?

Drx Choice Tension Headache is an over-the-counter tablet containing acetaminophen and caffeine used to relieve tension headaches. Acetaminophen reduces pain and fever while caffeine is a stimulant that can enhance the pain-relieving effects.

Is DRX CHOICE Tension Headache a controlled substance?

DRX CHOICE Tension Headache is not classified as a controlled substance by the DEA.

What is the generic name for DRX CHOICE Tension Headache?

The generic name for DRX CHOICE Tension Headache is Acetaminophen, Caffeine. There are 12 other brand versions of Acetaminophen, Caffeine.

What is the NDC code for DRX CHOICE Tension Headache 500 mg/1?

The NDC (National Drug Code) for DRX CHOICE Tension Headache 500 mg/1 is 68163-506, listed by Raritan Pharmaceuticals Inc..

Product NDC

68163-506

Package NDC

68163-506-15

Other Acetaminophen, Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)