Drugplain

ACETAMINOPHEN ASPIRIN AND CAFFEINE 250 mg/1

acetaminophen, aspirin and caffeine · TABLET, FILM COATED · Aurohealth LLC

No Recall HistoryCurrently in Shortage
Plain English

ACETAMINOPHEN ASPIRIN AND CAFFEINE is a tablet, film coated containing acetaminophen, aspirin and caffeine at 250 mg/1, taken oral. Manufactured by Aurohealth LLC.

Key Facts

Brand Name
ACETAMINOPHEN ASPIRIN AND CAFFEINE
Generic Name
acetaminophen, aspirin and caffeine
NDC Code (Product)
58602-882
Manufacturer
Aurohealth LLC
Strength
250 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
ANDA211695
Drug Class
Nonsteroidal Anti-inflammatory Drug [EPC]; Platelet Aggregation Inhibitor [EPC]
Marketing Start
06/23/2022

Recall History

No Recall History

Side Effects Reported to FDA

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

headache11 reports
off label use11 reports
completed suicide10 reports
hypertension8 reports
drug ineffective7 reports
dyspnoea7 reports
nausea7 reports
diarrhoea6 reports
feeling abnormal6 reports
hypotension6 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

USE(S) treats migraine

Dosage & Administration

DIRECTIONS • do not use more than directed • adults: take 2 caplets with a glass of water • if symptoms persist or worsen, ask your doctor • do not take more than 2 caplets in 24 hours, unless directed by a doctor • under 18 years of age: 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 2 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 c…

Frequently Asked Questions

What is ACETAMINOPHEN ASPIRIN AND CAFFEINE used for?

ACETAMINOPHEN ASPIRIN AND CAFFEINE contains acetaminophen, aspirin and caffeine. It is a tablet, film coated taken oral. Consult your doctor for specific uses.

Is ACETAMINOPHEN ASPIRIN AND CAFFEINE a controlled substance?

ACETAMINOPHEN ASPIRIN AND CAFFEINE is not classified as a controlled substance by the DEA.

What is the generic name for ACETAMINOPHEN ASPIRIN AND CAFFEINE?

The generic name for ACETAMINOPHEN ASPIRIN AND CAFFEINE is acetaminophen, aspirin and caffeine. There are 9 other brand versions of acetaminophen, aspirin and caffeine.

What is the NDC code for ACETAMINOPHEN ASPIRIN AND CAFFEINE 250 mg/1?

The NDC (National Drug Code) for ACETAMINOPHEN ASPIRIN AND CAFFEINE 250 mg/1 is 58602-882, listed by Aurohealth LLC.

Product NDC

58602-882

Package NDC

58602-882-21

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)