Drugplain

Excedrin Tension Headache 500 mg/1

Acetaminophen, Caffeine · TABLET, FILM COATED · Haleon US Holdings LLC

1 Recall on RecordCurrently in Shortage
Plain English

Excedrin Tension Headache is an over-the-counter oral tablet containing acetaminophen and caffeine used to relieve tension headaches. The combination works by reducing pain signals and using caffeine as a central nervous system stimulant to enhance the pain-relieving effects.

Key Facts

Brand Name
Excedrin Tension Headache
Generic Name
Acetaminophen, Caffeine
NDC Code (Product)
0067-8139
Manufacturer
Haleon US Holdings LLC
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
12/15/2016

Recall History

1 Recall on Record
Class II06/06/2013

Novartis Consumer Health

Defective container: products are packaged in pouches which may not have been fully sealed

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

drug ineffective2,047 reports
headache569 reports
nausea415 reports
fatigue358 reports
product use in unapproved indication301 reports
migraine282 reports
pain237 reports
dizziness227 reports
insomnia209 reports
vomiting208 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

Frequently Asked Questions

What is Excedrin Tension Headache used for?

Excedrin Tension Headache is an over-the-counter oral tablet containing acetaminophen and caffeine used to relieve tension headaches. The combination works by reducing pain signals and using caffeine as a central nervous system stimulant to enhance the pain-relieving effects.

Is Excedrin Tension Headache a controlled substance?

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

What is the generic name for Excedrin Tension Headache?

The generic name for Excedrin Tension Headache is Acetaminophen, Caffeine. There are 11 other brand versions of Acetaminophen, Caffeine.

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

The NDC (National Drug Code) for Excedrin Tension Headache 500 mg/1 is 0067-8139, listed by Haleon US Holdings LLC.