Acetaminophen and Ibuprofen Back Pain

Acetaminophen and Ibuprofen Back Pain is an FDA-registered drug product whose active ingredient is ACETAMINOPHEN AND IBUPROFEN. It is labelled by Aurohealth LLC taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 58602-895, application ANDA218359, label effective 20260428. It is one of 3 FDA drug label records sharing the active ingredient ACETAMINOPHEN AND IBUPROFEN. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing ACETAMINOPHEN AND IBUPROFEN are most often described in connection with: temporarily relieves, minor aches, pains due, backache muscular, pain arthritis, headache toothache, menstrual cramps. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

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

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 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 product ­ take more or for a longer time than directed Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

FDA lists 3 drug label records with ACETAMINOPHEN AND IBUPROFEN as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is Acetaminophen and Ibuprofen Back Pain used for?
Uses ­temporarily relieves minor aches and pains due to:­ backache muscular aches minor pain of arthritis headache toothache menstrual cramps

Who makes Acetaminophen and Ibuprofen Back Pain?
Aurohealth LLC is the labeler of record for Acetaminophen and Ibuprofen Back Pain. 3 FDA label records share the active ingredient ACETAMINOPHEN AND IBUPROFEN, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Acetaminophen and Ibuprofen Back Pain come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Acetaminophen and Ibuprofen Back Pain prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing ACETAMINOPHEN AND IBUPROFEN?
Yes. 3 FDA drug label records list ACETAMINOPHEN AND IBUPROFEN as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Acetaminophen and Ibuprofen Back Pain been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.