Drugplain

EXTRA PAIN RELIEF 250 mg/1

ACETAMINOPHEN, ASPIRIN AND CAFFEINE · TABLET, FILM COATED · TIME CAP LABS

No Recall HistoryCurrently in Shortage
Plain English

EXTRA PAIN RELIEF is a tablet, film coated containing acetaminophen, aspirin and caffeine at 250 mg/1, taken oral. Manufactured by TIME CAP LABS.

Key Facts

Brand Name
EXTRA PAIN RELIEF
Generic Name
ACETAMINOPHEN, ASPIRIN AND CAFFEINE
NDC Code (Product)
49483-370
Manufacturer
TIME CAP LABS
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
11/01/2013

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
abdominal pain upper6 reports
diarrhoea6 reports
feeling abnormal6 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

DIRECTIOINS 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 co

Frequently Asked Questions

What is EXTRA PAIN RELIEF used for?

EXTRA PAIN RELIEF contains ACETAMINOPHEN, ASPIRIN AND CAFFEINE. It is a tablet, film coated taken oral. Consult your doctor for specific uses.

Is EXTRA PAIN RELIEF a controlled substance?

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

What is the generic name for EXTRA PAIN RELIEF?

The generic name for EXTRA PAIN RELIEF is ACETAMINOPHEN, ASPIRIN AND CAFFEINE. There are 11 other brand versions of ACETAMINOPHEN, ASPIRIN AND CAFFEINE.

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

The NDC (National Drug Code) for EXTRA PAIN RELIEF 250 mg/1 is 49483-370, listed by TIME CAP LABS.