Drugplain

EXCEDRIN MIGRAINE 250 mg/1

Acetaminophen, Aspirin (NSAID) and Caffeine · TABLET, FILM COATED · Jones Healthcare Group - Packaging Services, Inc

3 Recalls on RecordCurrently in Shortage
Plain English

EXCEDRIN MIGRAINE is a tablet, film coated containing acetaminophen, aspirin (nsaid) and caffeine at 250 mg/1, taken oral. Manufactured by Jones Healthcare Group - Packaging Services, Inc.

Key Facts

Brand Name
EXCEDRIN MIGRAINE
Generic Name
Acetaminophen, Aspirin (NSAID) and Caffeine
NDC Code (Product)
67414-239
Manufacturer
Jones Healthcare Group - Packaging Services, Inc
Strength
250 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
M013
Drug Class
Nonsteroidal Anti-inflammatory Drug [EPC]; Platelet Aggregation Inhibitor [EPC]
Marketing Start
01/24/2018

Recall History

3 Recalls 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
Class II12/26/2025

GOLD STAR DISTRIBUTION INC

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

OngoingVoluntary: Firm initiated
Class II06/23/2022

Family Dollar Stores, Llc.

CGMP Deviations: product held outside appropriate storage temperature conditions.

OngoingVoluntary: Firm initiated

Side Effects Reported to FDA

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

drug ineffective3,801 reports
product use in unapproved indication2,050 reports
drug effective for unapproved indication1,572 reports
headache1,137 reports
nausea1,042 reports
fatigue625 reports
dizziness598 reports
migraine595 reports
pain538 reports
vomiting524 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Use treats migraine

Dosage & Administration

Directions do not use more than directed adults: take 2 caplets with a glass of water if symptoms persist or worsen, ask your doctor do not take more than 2 caplets in 24 hours, unless directed by a doctor under 18 years of age: 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 2 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 containing prescription or non

Frequently Asked Questions

What is EXCEDRIN MIGRAINE used for?

EXCEDRIN MIGRAINE contains Acetaminophen, Aspirin (NSAID) and Caffeine. It is a tablet, film coated taken oral. Consult your doctor for specific uses.

Is EXCEDRIN MIGRAINE a controlled substance?

EXCEDRIN MIGRAINE is not classified as a controlled substance by the DEA.

What is the generic name for EXCEDRIN MIGRAINE?

The generic name for EXCEDRIN MIGRAINE is Acetaminophen, Aspirin (NSAID) and Caffeine. There are no other listed brand versions of Acetaminophen, Aspirin (NSAID) and Caffeine.

What is the NDC code for EXCEDRIN MIGRAINE 250 mg/1?

The NDC (National Drug Code) for EXCEDRIN MIGRAINE 250 mg/1 is 67414-239, listed by Jones Healthcare Group - Packaging Services, Inc.

Product NDC

67414-239

Package NDC

67414-239-02

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

Data from openFDA · Public domain (CC0 1.0)