Drugplain

Extra Strength Pain Reliever 250 mg/1

ACETAMINOPHEN, ASPIRIN, and CAFFEINE · CAPSULE, COATED · JHK Inc dba American Safety & First Aid

3 Recalls on RecordCurrently in Shortage
Plain English

This over-the-counter pain reliever combines acetaminophen, aspirin, and caffeine in capsule form to help reduce pain and fever. The aspirin and caffeine work together with acetaminophen to provide extra-strength relief for minor aches and pains.

Key Facts

Brand Name
Extra Strength Pain Reliever
Generic Name
ACETAMINOPHEN, ASPIRIN, and CAFFEINE
NDC Code (Product)
73598-1372
Manufacturer
JHK Inc dba American Safety & First Aid
Strength
250 mg/1
Dosage Form
CAPSULE, COATED
Route
ORAL
Marketing Status
Application #
M013
Drug Class
Nonsteroidal Anti-inflammatory Drug [EPC]; Platelet Aggregation Inhibitor [EPC]
Marketing Start
02/02/2000

Recall History

3 Recalls on Record
Class I09/25/2015

Medline Industries Inc

Labeling: Label Error on Declared Strength- Bottles containing 500 mg acetaminophen tablets mislabeled to contain 325 mg tablets.

TerminatedVoluntary: Firm initiated
Class III07/07/2021

LNK International, Inc.

Labeling: Not Elsewhere Classified The primary label contains the words "enteric coated" but the tablet is not enteric coated and should only say 'coated tablet'

TerminatedVoluntary: Firm initiated
Class II12/06/2021

Medique Products

CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

off label use22,535 reports
fatigue20,774 reports
drug ineffective20,167 reports
pain18,331 reports
nausea18,026 reports
headache17,243 reports
toxicity to various agents15,664 reports
dyspnoea14,722 reports
arthralgia14,442 reports
pyrexia14,343 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 and menstrual cramps

Dosage & Administration

Directions do not use more than directed drink a full glass of water with each dose adults and children 12 years of age 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: 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. Allergy alert: Aspirin may cause a severe allergic reaction which may include: hives facial swelling asthma (wheezing) shock Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 8 caplets 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 non…

Frequently Asked Questions

What is Extra Strength Pain Reliever used for?

This over-the-counter pain reliever combines acetaminophen, aspirin, and caffeine in capsule form to help reduce pain and fever. The aspirin and caffeine work together with acetaminophen to provide extra-strength relief for minor aches and pains.

Is Extra Strength Pain Reliever a controlled substance?

Extra Strength Pain Reliever is not classified as a controlled substance by the DEA.

What is the generic name for Extra Strength Pain Reliever?

The generic name for Extra Strength Pain Reliever is ACETAMINOPHEN, ASPIRIN, and CAFFEINE. There are 11 other brand versions of ACETAMINOPHEN, ASPIRIN, and CAFFEINE.

What is the NDC code for Extra Strength Pain Reliever 250 mg/1?

The NDC (National Drug Code) for Extra Strength Pain Reliever 250 mg/1 is 73598-1372, listed by JHK Inc dba American Safety & First Aid.

Product NDC

73598-1372

Package NDC

73598-1372-1

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)