Drugplain

Ibuprofen and Pseudoephedrine HCl 200 mg/1

Ibuprofen and Pseudoephedrine HCl · CAPSULE, LIQUID FILLED · Cardinal Health

No Recall History
Plain English

This medication combines ibuprofen, a nonsteroidal anti-inflammatory drug that reduces pain and fever, with pseudoephedrine, a decongestant that relieves nasal congestion. It is used to treat cold and flu symptoms including aches, fever, and sinus congestion.

Key Facts

Brand Name
Ibuprofen and Pseudoephedrine HCl
Generic Name
Ibuprofen and Pseudoephedrine HCl
NDC Code (Product)
70000-0606
Manufacturer
Cardinal Health
Strength
200 mg/1
Dosage Form
CAPSULE, LIQUID FILLED
Route
ORAL
Marketing Status
Application #
ANDA209235
Drug Class
Nonsteroidal Anti-inflammatory Drug [EPC]
Marketing Start
05/07/2022

Recall History

No Recall History

Side Effects Reported to FDA

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

drug ineffective3 reports
completed suicide2 reports
multiple drug overdose2 reports
protein total decreased2 reports
suicide attempt2 reports
abdominal pain1 reports
aggression1 reports
analgesic drug level increased1 reports
ankle fracture1 reports
arthritis1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses temporarily relieves these symptoms associated with the common cold or flu: headache sinus pressure nasal congestion minor body aches and pains fever

Dosage & Administration

Directions ● do not take more than directed ● the smallest effective dose should be used ● adults and children 12 years of age and over: ● take 1 capsule every 4 to 6 hours while symptoms persist. If symptoms do not respond to 1 capsule, 2 capsules may be used. ● do not use more than 6 capsules in any 24-hour period unless directed by a doctor ● children under 12 years of age: do not use Other information each capsule contains: potassium 20 mg store at 20° to 25°C (68° to 77°F). Avoid excessive heat above 40°C (104°F). read all warnings and directions before use. Keep carton.

Warnings

Warnings 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. 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.

Frequently Asked Questions

What is Ibuprofen and Pseudoephedrine HCl used for?

This medication combines ibuprofen, a nonsteroidal anti-inflammatory drug that reduces pain and fever, with pseudoephedrine, a decongestant that relieves nasal congestion. It is used to treat cold and flu symptoms including aches, fever, and sinus congestion.

Is Ibuprofen and Pseudoephedrine HCl a controlled substance?

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

What is the generic name for Ibuprofen and Pseudoephedrine HCl?

The generic name for Ibuprofen and Pseudoephedrine HCl is Ibuprofen and Pseudoephedrine HCl. There are no other listed brand versions of Ibuprofen and Pseudoephedrine HCl.

What is the NDC code for Ibuprofen and Pseudoephedrine HCl 200 mg/1?

The NDC (National Drug Code) for Ibuprofen and Pseudoephedrine HCl 200 mg/1 is 70000-0606, listed by Cardinal Health.

Product NDC

70000-0606

Package NDC

70000-0606-1

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)