Drugplain

Excedrin Extra Strength Geltabs 250 mg/1

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

No Recall HistoryCurrently in Shortage
Plain English

Excedrin Extra Strength Geltabs is an over-the-counter pain reliever that combines acetaminophen, aspirin, and caffeine to treat headaches, muscle aches, and minor arthritis pain. The three active ingredients work together to provide faster and longer-lasting relief than single-ingredient pain relievers.

Key Facts

Brand Name
Excedrin Extra Strength Geltabs
Generic Name
Acetaminophen, Asprin, Caffeine
NDC Code (Product)
0067-2021
Manufacturer
Haleon US Holdings LLC
Strength
250 mg/1
Dosage Form
TABLET, COATED
Route
ORAL
Marketing Status
Application #
M013
Drug Class
Nonsteroidal Anti-inflammatory Drug [EPC]; Platelet Aggregation Inhibitor [EPC]
Marketing Start
09/13/2011

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
migraine262 reports
product use in unapproved indication259 reports
pain221 reports
dizziness212 reports
insomnia203 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 & 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 and over: take 2 geltabs every 6 hours; not more than 8 geltabs 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 geltabs 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 Geltabs used for?

Excedrin Extra Strength Geltabs is an over-the-counter pain reliever that combines acetaminophen, aspirin, and caffeine to treat headaches, muscle aches, and minor arthritis pain. The three active ingredients work together to provide faster and longer-lasting relief than single-ingredient pain relievers.

Is Excedrin Extra Strength Geltabs a controlled substance?

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

What is the generic name for Excedrin Extra Strength Geltabs?

The generic name for Excedrin Extra Strength Geltabs is Acetaminophen, Asprin, Caffeine. There are 1 other brand versions of Acetaminophen, Asprin, Caffeine.

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

The NDC (National Drug Code) for Excedrin Extra Strength Geltabs 250 mg/1 is 0067-2021, listed by Haleon US Holdings LLC.

Product NDC

0067-2021

Package NDC

0067-2021-20

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

Data from openFDA · Public domain (CC0 1.0)