Drugplain

Headache Relief Extra Strength 250 mg/1

Acetaminophen, Aspirin and Caffeine · TABLET, FILM COATED · Salado Sales, Inc.

No Recall HistoryCurrently in Shortage
Plain English

Headache Relief Extra Strength is an over-the-counter oral tablet that combines acetaminophen, aspirin, and caffeine to help relieve headache pain. This combination medication works through multiple mechanisms to reduce pain and inflammation associated with headaches.

Key Facts

Brand Name
Headache Relief Extra Strength
Generic Name
Acetaminophen, Aspirin and Caffeine
NDC Code (Product)
57243-334
Manufacturer
Salado Sales, 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
03/13/2008

Recall History

No Recall History

Side Effects Reported to FDA

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

nausea14 reports
off label use14 reports
completed suicide12 reports
headache12 reports
drug ineffective11 reports
pruritus10 reports
dyspnoea8 reports
feeling abnormal8 reports
hypertension8 reports
asthenia7 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 Extra Strength used for?

Headache Relief Extra Strength is an over-the-counter oral tablet that combines acetaminophen, aspirin, and caffeine to help relieve headache pain. This combination medication works through multiple mechanisms to reduce pain and inflammation associated with headaches.

Is Headache Relief Extra Strength a controlled substance?

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

What is the generic name for Headache Relief Extra Strength?

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

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

The NDC (National Drug Code) for Headache Relief Extra Strength 250 mg/1 is 57243-334, listed by Salado Sales, Inc..

Product NDC

57243-334

Package NDC

57243-334-08

Other Headache Relief Extra Strength Dosages

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)