Drugplain

Headache Relief 250 mg/1

Acetaminophen, Aspirin, Caffeine · TABLET, FILM COATED · Chain Drug Marketing Association, Inc.

2 Recalls on RecordCurrently in Shortage
Plain English

Headache Relief is a tablet, film coated containing acetaminophen, aspirin, caffeine at 250 mg/1, taken oral. Manufactured by Chain Drug Marketing Association, Inc..

Key Facts

Brand Name
Headache Relief
Generic Name
Acetaminophen, Aspirin, Caffeine
NDC Code (Product)
83324-063
Manufacturer
Chain Drug Marketing Association, 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
06/19/2025

Recall History

2 Recalls on Record
Class I07/20/2018

King Bio Inc.

Microbial contamination

TerminatedVoluntary: Firm initiated
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

pain86 reports
off label use79 reports
drug ineffective76 reports
dyspnoea64 reports
drug interaction63 reports
sinusitis59 reports
headache58 reports
pruritus56 reports
lower respiratory tract infection54 reports
mobility decreased50 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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

Dosage & Administration

Directions do not take more than directed drink a full glass of water with each dose adults and children 12 years and over: take 2 caplets every 6 hours. Do not take 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: shock facial swelling hives asthma (wheezing) 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 4,000 mg of acetaminophen in 24 hours 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 take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using t

Frequently Asked Questions

What is Headache Relief used for?

Headache Relief contains Acetaminophen, Aspirin, Caffeine. It is a tablet, film coated taken oral. Consult your doctor for specific uses.

Is Headache Relief a controlled substance?

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

What is the generic name for Headache Relief?

The generic name for Headache Relief is Acetaminophen, Aspirin, Caffeine. There are 10 other brand versions of Acetaminophen, Aspirin, Caffeine.

What is the NDC code for Headache Relief 250 mg/1?

The NDC (National Drug Code) for Headache Relief 250 mg/1 is 83324-063, listed by Chain Drug Marketing Association, Inc..