Drugplain

Excedrin Extra Strength Headache 250 mg/1

ACETAMINOPHEN, ASPIRIN, CAFFEINE · TABLET, FILM COATED · JC World Bell Wholesale Co., Inc

No Recall HistoryCurrently in Shortage
Plain English

Excedrin Extra Strength Headache is a tablet, film coated containing acetaminophen, aspirin, caffeine at 250 mg/1, taken topical. Manufactured by JC World Bell Wholesale Co., Inc.

Key Facts

Brand Name
Excedrin Extra Strength Headache
Generic Name
ACETAMINOPHEN, ASPIRIN, CAFFEINE
NDC Code (Product)
50269-158
Manufacturer
JC World Bell Wholesale Co., Inc
Strength
250 mg/1
Dosage Form
TABLET, FILM COATED
Route
TOPICAL
Marketing Status
Application #
NDA020802
Drug Class
Nonsteroidal Anti-inflammatory Drug [EPC]; Platelet Aggregation Inhibitor [EPC]
Marketing Start
01/01/2024

Recall History

No Recall History

Side Effects Reported to FDA

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

drug ineffective2,002 reports
headache531 reports
nausea392 reports
fatigue343 reports
product use in unapproved indication263 reports
migraine262 reports
pain221 reports
dizziness211 reports
insomnia204 reports
diarrhoea194 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses temporarily relieves minor aches and pains due to: headache a cold arthritis muscular aches toothache premenstrual and menstrual cramps

Dosage & Administration

Directions • do not use more than directed • drink a full glass of water with each dose • adults and children 12 years of age and over: take 2 caplets every 6 hours; not more than 8 caplets in 24 hours • children under 12 years: ask a doctor

Warnings

Warnings Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness. 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. Allergy alert: Aspirin may cause a severe allergic reaction which may include: • hives • facial swelling • asthma (wheezing) • shock Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take • more than 8 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 Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you • are age 60 or older • have had stomach ulcers or bleeding problems • take a blood thinning (anticoagulant) or steroid drug • take other drugs co…

Frequently Asked Questions

What is Excedrin Extra Strength Headache used for?

Excedrin Extra Strength Headache contains ACETAMINOPHEN, ASPIRIN, CAFFEINE. It is a tablet, film coated taken topical. Consult your doctor for specific uses.

Is Excedrin Extra Strength Headache a controlled substance?

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

What is the generic name for Excedrin Extra Strength Headache?

The generic name for Excedrin Extra Strength Headache is ACETAMINOPHEN, ASPIRIN, CAFFEINE. There are 11 other brand versions of ACETAMINOPHEN, ASPIRIN, CAFFEINE.

What is the NDC code for Excedrin Extra Strength Headache 250 mg/1?

The NDC (National Drug Code) for Excedrin Extra Strength Headache 250 mg/1 is 50269-158, listed by JC World Bell Wholesale Co., Inc.

Product NDC

50269-158

Package NDC

50269-158-01

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)