Drugplain

EXTRA STRENGTH PAIN RELIEF 250 mg/1

Acetaminophen, Aspirin, Caffeine · TABLET · BETTER LIVING BRANDS, LLC

2 Recalls on RecordCurrently in Shortage
Plain English

This over-the-counter tablet combines acetaminophen, aspirin, and caffeine to help relieve mild to moderate pain and headaches. The aspirin and acetaminophen work to reduce pain and inflammation, while the caffeine enhances their effectiveness.

Key Facts

Brand Name
EXTRA STRENGTH PAIN RELIEF
Generic Name
Acetaminophen, Aspirin, Caffeine
NDC Code (Product)
21130-037
Manufacturer
BETTER LIVING BRANDS, LLC
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
06/01/2023

Recall History

2 Recalls on Record
Class II01/24/2022

Ultra Seal Corporation

cGMP deviations

TerminatedVoluntary: Firm initiated
Class II11/01/2024

JR Watkins

cGMP Deviations

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

off label use22,436 reports
fatigue20,494 reports
drug ineffective18,217 reports
pain18,170 reports
nausea17,661 reports
headache16,755 reports
toxicity to various agents15,661 reports
dyspnoea14,637 reports
arthralgia14,330 reports
pyrexia14,291 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses temporarily relieves minor aches and pains due to: the common cold headache backache minor pain of arthritis toothache muscular aches premenstrual and menstrual cramps temporarily reduces fever

Dosage & Administration

Directions do not take more than directed (see overdose warning ) adults and children 12 years and over take 2 caplets every 6 hours while symptoms last do not take more than 6 caplets in 24 hours, unless directed by a doctor do not use for more than 10 days unless directed by a doctor children under 12 years ask a doctor

Warnings

Warnings 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 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. Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are allergic to acetaminophen or any of the inactive ingredients in this product Ask a doctor before use if you have liver disease. Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin Stop use and ask a doctor if pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning In case of overdose, get medica…

Frequently Asked Questions

What is EXTRA STRENGTH PAIN RELIEF used for?

This over-the-counter tablet combines acetaminophen, aspirin, and caffeine to help relieve mild to moderate pain and headaches. The aspirin and acetaminophen work to reduce pain and inflammation, while the caffeine enhances their effectiveness.

Is EXTRA STRENGTH PAIN RELIEF a controlled substance?

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

What is the generic name for EXTRA STRENGTH PAIN RELIEF?

The generic name for EXTRA STRENGTH PAIN RELIEF is Acetaminophen, Aspirin, Caffeine. There are 11 other brand versions of Acetaminophen, Aspirin, Caffeine.

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

The NDC (National Drug Code) for EXTRA STRENGTH PAIN RELIEF 250 mg/1 is 21130-037, listed by BETTER LIVING BRANDS, LLC.

Product NDC

21130-037

Package NDC

21130-037-01

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)