Drugplain

Acetaminophen and Ibuprofen 250 mg/1

Acetaminophen and Ibuprofen · TABLET · LEADER/ Cardinal Health 110, Inc.

1 Recall on RecordCurrently in Shortage
Plain English

Acetaminophen and Ibuprofen is a tablet containing acetaminophen and ibuprofen at 250 mg/1, taken oral. Manufactured by LEADER/ Cardinal Health 110, Inc..

Key Facts

Brand Name
Acetaminophen and Ibuprofen
Generic Name
Acetaminophen and Ibuprofen
NDC Code (Product)
70000-0622
Manufacturer
LEADER/ Cardinal Health 110, Inc.
Strength
250 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
ANDA216592
Drug Class
Nonsteroidal Anti-inflammatory Drug [EPC]
Marketing Start
07/15/2023

Recall History

1 Recall on Record
Class II03/13/2025

Glenmark Pharmaceuticals Inc., USA

CGMP Deviations

OngoingVoluntary: Firm initiated

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 Acetaminophen and Ibuprofen used for?

Acetaminophen and Ibuprofen contains Acetaminophen and Ibuprofen. It is a tablet taken oral. Consult your doctor for specific uses.

Is Acetaminophen and Ibuprofen a controlled substance?

Acetaminophen and Ibuprofen is not classified as a controlled substance by the DEA.

What is the generic name for Acetaminophen and Ibuprofen?

The generic name for Acetaminophen and Ibuprofen is Acetaminophen and Ibuprofen. There are 7 other brand versions of Acetaminophen and Ibuprofen.

What is the NDC code for Acetaminophen and Ibuprofen 250 mg/1?

The NDC (National Drug Code) for Acetaminophen and Ibuprofen 250 mg/1 is 70000-0622, listed by LEADER/ Cardinal Health 110, Inc..

Product NDC

70000-0622

Package NDC

70000-0622-1

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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