Drugplain

Topcare Dual Action Back Pain 250 mg/1

acetaminophen, ibuprofen · TABLET, FILM COATED · Topco Associates LLC

No Recall HistoryCurrently in Shortage
Plain English

Topcare Dual Action Back Pain is a tablet, film coated containing acetaminophen, ibuprofen at 250 mg/1, taken oral. Manufactured by Topco Associates LLC.

Key Facts

Brand Name
Topcare Dual Action Back Pain
Generic Name
acetaminophen, ibuprofen
NDC Code (Product)
76162-520
Manufacturer
Topco Associates LLC
Strength
250 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
ANDA214836
Drug Class
Nonsteroidal Anti-inflammatory Drug [EPC]
Marketing Start
01/31/2024

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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

Frequently Asked Questions

What is Topcare Dual Action Back Pain used for?

Topcare Dual Action Back Pain contains acetaminophen, ibuprofen. It is a tablet, film coated taken oral. Consult your doctor for specific uses.

Is Topcare Dual Action Back Pain a controlled substance?

Topcare Dual Action Back Pain is not classified as a controlled substance by the DEA.

What is the generic name for Topcare Dual Action Back Pain?

The generic name for Topcare Dual Action Back Pain is acetaminophen, ibuprofen. There are 12 other brand versions of acetaminophen, ibuprofen.

What is the NDC code for Topcare Dual Action Back Pain 250 mg/1?

The NDC (National Drug Code) for Topcare Dual Action Back Pain 250 mg/1 is 76162-520, listed by Topco Associates LLC.