Drugplain

Headache Relief Extra Strength 250 mg/1

Aspirin, Acetaminophen, Caffeine · TABLET, FILM COATED · Rite Aid Corporation

No Recall History
Plain English

Headache Relief Extra Strength is a tablet, film coated containing aspirin, acetaminophen, caffeine at 250 mg/1, taken oral. Manufactured by Rite Aid Corporation.

Key Facts

Brand Name
Headache Relief Extra Strength
Generic Name
Aspirin, Acetaminophen, Caffeine
NDC Code (Product)
11822-3343
Manufacturer
Rite Aid Corporation
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
09/27/2024

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

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 Aspirin, Acetaminophen, Caffeine. There are 2 other brand versions of Aspirin, Acetaminophen, 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 11822-3343, listed by Rite Aid Corporation.

Product NDC

11822-3343

Package NDC

11822-3343-6

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

Data from openFDA · Public domain (CC0 1.0)