Medique Pain Off 250 mg/1

Acetaminophen, Aspirin, Caffeine · TABLET, FILM COATED · Unifirst First Aid Corporation

1 Recall on RecordCurrently in Shortage

Plain English

Medique Pain Off is a tablet, film coated containing acetaminophen, aspirin, caffeine at 250 mg/1, taken oral. Manufactured by Unifirst First Aid Corporation.

Key Facts

Brand Name: Medique Pain Off
Generic Name: Acetaminophen, Aspirin, Caffeine
NDC Code (Product): 47682-238
Manufacturer: Unifirst First 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: 06/01/2021

Recall History

1 Recall on Record

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

completed suicide2 reports

acute coronary syndrome1 reports

acute myocardial infarction1 reports

confusional state1 reports

expired product administered1 reports

feeling abnormal1 reports

foetal death1 reports

gastric ulcer1 reports

gastrointestinal haemorrhage1 reports

haemorrhage1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses temporarily relieves minor aches and pains due to ■ headache ■ muscular aches ■ arthritis pain ■ a cold ■ 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 and over) Take 2 caplets every 6 hours as needed; 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 (NSAIDs) 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 oth…

Frequently Asked Questions

What is Medique Pain Off used for?

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

Is Medique Pain Off a controlled substance?

Medique Pain Off is not classified as a controlled substance by the DEA.

What is the generic name for Medique Pain Off?

The generic name for Medique Pain Off is Acetaminophen, Aspirin, Caffeine. There are 12 other brand versions of Acetaminophen, Aspirin, Caffeine.

What is the NDC code for Medique Pain Off 250 mg/1?

The NDC (National Drug Code) for Medique Pain Off 250 mg/1 is 47682-238, listed by Unifirst First Aid Corporation.

Product NDC

47682-238

Package NDC

47682-238-13

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)