Drugplain

dual action pain reliever 250 mg/1

Acetaminophen and Ibuprofen · TABLET, FILM COATED · Bionpharma Inc.

No Recall HistoryCurrently in Shortage
Plain English

This over-the-counter tablet combines acetaminophen and ibuprofen to relieve pain and reduce inflammation. It is taken by mouth and belongs to a class of medications called nonsteroidal anti-inflammatory drugs.

Key Facts

Brand Name
dual action pain reliever
Generic Name
Acetaminophen and Ibuprofen
NDC Code (Product)
69452-447
Manufacturer
Bionpharma Inc.
Strength
250 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
ANDA216999
Drug Class
Nonsteroidal Anti-inflammatory Drug [EPC]
Marketing Start
08/08/2024

Recall History

No Recall History

Side Effects Reported to FDA

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

drug ineffective47 reports
drug effective for unapproved indication30 reports
therapeutic product effect incomplete27 reports
drug effect less than expected15 reports
underdose13 reports
overdose10 reports
incorrect dose administered9 reports
drug ineffective for unapproved indication8 reports
hypersensitivity7 reports
off label use6 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses temporarily relieves minor aches and pains due to: headache toothache backache menstrual cramps muscular aches minor pain of arthritis

Dosage & Administration

Directions ■ do not take more than directed adults and children 12 years and over ■ take 2 caplets every 8 hours while symptoms persist children under 12 years ■ ask a doctor ■ do not take more than 6 caplets in 24 hours, unless directed by a doctor

Warnings

Warnings Acetaminophen liver damage warning: This product contains acetaminophen. Severe liver damage may occur if you take: with other drugs containing acetaminophen more than 6 caplets in 24 hours, which is the maximum daily amount for this product 3 or more alcoholic drinks every day while using this product. Acetaminophen allergy alert: may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If skin reaction occurs, stop use and seek medical help right away. NSAID allergy alert: ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives facial swelling asthma (wheezing) shock skin reddening rash blisters If an allergic reaction occurs, stop use and seek medical help right away. NSAID 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 nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] have 3 or more alcoholic drinks every day while using this p…

Frequently Asked Questions

What is dual action pain reliever used for?

This over-the-counter tablet combines acetaminophen and ibuprofen to relieve pain and reduce inflammation. It is taken by mouth and belongs to a class of medications called nonsteroidal anti-inflammatory drugs.

Is dual action pain reliever a controlled substance?

dual action pain reliever is not classified as a controlled substance by the DEA.

What is the generic name for dual action pain reliever?

The generic name for dual action pain reliever is Acetaminophen and Ibuprofen. There are 10 other brand versions of Acetaminophen and Ibuprofen.

What is the NDC code for dual action pain reliever 250 mg/1?

The NDC (National Drug Code) for dual action pain reliever 250 mg/1 is 69452-447, listed by Bionpharma Inc..

Product NDC

69452-447

Package NDC

69452-447-22

Other Acetaminophen Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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