EXTRA STRENGTH HEADACHE RELIEF 250 mg/1

ACETAMINOPHEN, ASPIRIN, CAFFEINE · TABLET · WALGREENS

1 Recall on RecordCurrently in Shortage

Plain English

Extra Strength Headache Relief is an over-the-counter tablet containing acetaminophen, aspirin, and caffeine that is taken by mouth to relieve headache pain. This combination medication works through multiple mechanisms to help reduce pain and may be more effective than single-ingredient pain relievers for some people.

Key Facts

Brand Name: EXTRA STRENGTH HEADACHE RELIEF
Generic Name: ACETAMINOPHEN, ASPIRIN, CAFFEINE
NDC Code (Product): 0363-7214
Manufacturer: WALGREENS
Strength: 250 mg/1
Dosage Form: TABLET
Route: ORAL
Marketing Status
Application #: M013
Drug Class: Nonsteroidal Anti-inflammatory Drug [EPC]; Platelet Aggregation Inhibitor [EPC]
Marketing Start: 11/17/2020

Recall History

1 Recall on Record

Class III08/03/2020

Ultra Seal Corporation

Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

completed suicide12 reports

headache12 reports

hypertension11 reports

off label use11 reports

feeling abnormal9 reports

nausea9 reports

drug ineffective8 reports

dyspnoea7 reports

chest pain6 reports

diarrhoea6 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 (see Overdose Warning ) drink a full glass of water with each dose adults and children 12 years 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 Aspirin may cause a severe allergic reaction which may include: hives facial swelling asthma (wheezing) shock 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 8 tablets 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 nonprescription NSAIDs…

Frequently Asked Questions

What is EXTRA STRENGTH HEADACHE RELIEF used for?

Is EXTRA STRENGTH HEADACHE RELIEF a controlled substance?

EXTRA STRENGTH HEADACHE RELIEF is not classified as a controlled substance by the DEA.

What is the generic name for EXTRA STRENGTH HEADACHE RELIEF?

The generic name for EXTRA STRENGTH HEADACHE RELIEF is ACETAMINOPHEN, ASPIRIN, CAFFEINE. There are 12 other brand versions of ACETAMINOPHEN, ASPIRIN, CAFFEINE.

What is the NDC code for EXTRA STRENGTH HEADACHE RELIEF 250 mg/1?

The NDC (National Drug Code) for EXTRA STRENGTH HEADACHE RELIEF 250 mg/1 is 0363-7214, listed by WALGREENS.

Product NDC

0363-7214

Package NDC

0363-7214-25

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)