Acetaminophen and Ibuprofen Back Pain 250 mg/1

Acetaminophen and Ibuprofen · TABLET · Granules Pharmaceuticals Inc.

No Recall HistoryCurrently in Shortage

Plain English

This tablet combines acetaminophen and ibuprofen to help relieve back pain and is available over-the-counter without a prescription. Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) that reduces inflammation and pain, while acetaminophen works as an additional pain reliever.

Key Facts

Brand Name: Acetaminophen and Ibuprofen Back Pain
Generic Name: Acetaminophen and Ibuprofen
NDC Code (Product): 70010-213
Manufacturer: Granules Pharmaceuticals Inc.
Strength: 250 mg/1
Dosage Form: TABLET
Route: ORAL
Marketing Status
Application #: ANDA216592
Drug Class: Nonsteroidal Anti-inflammatory Drug [EPC]
Marketing Start: 07/14/2023

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: o backache o muscular aches o minor pain of arthritis o headache o toothache o menstrual cramps

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 pr…

Frequently Asked Questions

What is Acetaminophen and Ibuprofen Back Pain used for?

Is Acetaminophen and Ibuprofen Back Pain a controlled substance?

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

What is the generic name for Acetaminophen and Ibuprofen Back Pain?

The generic name for Acetaminophen and Ibuprofen Back Pain is Acetaminophen and Ibuprofen. There are 12 other brand versions of Acetaminophen and Ibuprofen.

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

The NDC (National Drug Code) for Acetaminophen and Ibuprofen Back Pain 250 mg/1 is 70010-213, listed by Granules Pharmaceuticals Inc..

Product NDC

70010-213

Package NDC

70010-213-26

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)