Drugplain

Leader Dual Action Pain Reliever 250 mg/1

Acetaminophen, Ibuprofen · TABLET, FILM COATED · Cardinal Health 110, LLC. dba Leader

No Recall HistoryCurrently in Shortage
Plain English

Leader Dual Action Pain Reliever is a tablet, film coated containing acetaminophen, ibuprofen at 250 mg/1, taken oral. Manufactured by Cardinal Health 110, LLC. dba Leader.

Key Facts

Brand Name
Leader Dual Action Pain Reliever
Generic Name
Acetaminophen, Ibuprofen
NDC Code (Product)
70000-0737
Manufacturer
Cardinal Health 110, LLC. dba Leader
Strength
250 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
ANDA214836
Drug Class
Nonsteroidal Anti-inflammatory Drug [EPC]
Marketing Start
09/30/2025

Recall History

No Recall History

Side Effects Reported to FDA

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

back injury1 reports
back pain1 reports
bone disorder1 reports
cartilage injury1 reports
constipation1 reports
diarrhoea1 reports
fall1 reports
fractured sacrum1 reports
haematoma muscle1 reports
nausea1 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

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 Leader Dual Action Pain Reliever used for?

Leader Dual Action Pain Reliever contains Acetaminophen, Ibuprofen. It is a tablet, film coated taken oral. Consult your doctor for specific uses.

Is Leader Dual Action Pain Reliever a controlled substance?

Leader Dual Action Pain Reliever is not classified as a controlled substance by the DEA.

What is the generic name for Leader Dual Action Pain Reliever?

The generic name for Leader Dual Action Pain Reliever is Acetaminophen, Ibuprofen. There are 11 other brand versions of Acetaminophen, Ibuprofen.

What is the NDC code for Leader Dual Action Pain Reliever 250 mg/1?

The NDC (National Drug Code) for Leader Dual Action Pain Reliever 250 mg/1 is 70000-0737, listed by Cardinal Health 110, LLC. dba Leader.