Drugplain

Ibuprofen and Pseudoephedrine Hydrochloride 200 mg/1

Ibuprofen and Pseudoephedrine Hydrochloride · TABLET, COATED · Rite-Aid

No Recall History
Plain English

Ibuprofen and Pseudoephedrine Hydrochloride is a tablet, coated containing ibuprofen and pseudoephedrine hydrochloride at 200 mg/1, taken oral. Manufactured by Rite-Aid.

Key Facts

Brand Name
Ibuprofen and Pseudoephedrine Hydrochloride
Generic Name
Ibuprofen and Pseudoephedrine Hydrochloride
NDC Code (Product)
11822-0084
Manufacturer
Rite-Aid
Strength
200 mg/1
Dosage Form
TABLET, COATED
Route
ORAL
Marketing Status
Application #
ANDA074567
Drug Class
Nonsteroidal Anti-inflammatory Drug [EPC]
Marketing Start
02/01/2018

Recall History

No Recall History

Side Effects Reported to FDA

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

drug ineffective39 reports
joint swelling35 reports
arthralgia32 reports
musculoskeletal stiffness30 reports
pain in extremity28 reports
drug intolerance24 reports
treatment failure23 reports
musculoskeletal pain22 reports
therapeutic product effect incomplete22 reports
peripheral swelling21 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 fever sinus pressure nasal congestion minor body aches and pains

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 caplet every 4 to 6 hours while symptoms persist. If symptoms do not respond to 1 caplet, 2 caplets may be used. do not use more than 6 caplets in any 24-hour period unless directed by a doctor children under 12 years of age: do not use

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. Do not use in children under 12 years of age if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery if you are now taking a prescription monoamine oxidase inhibitor (MA…

Frequently Asked Questions

What is Ibuprofen and Pseudoephedrine Hydrochloride used for?

Ibuprofen and Pseudoephedrine Hydrochloride contains Ibuprofen and Pseudoephedrine Hydrochloride. It is a tablet, coated taken oral. Consult your doctor for specific uses.

Is Ibuprofen and Pseudoephedrine Hydrochloride a controlled substance?

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

What is the generic name for Ibuprofen and Pseudoephedrine Hydrochloride?

The generic name for Ibuprofen and Pseudoephedrine Hydrochloride is Ibuprofen and Pseudoephedrine Hydrochloride. There are 4 other brand versions of Ibuprofen and Pseudoephedrine Hydrochloride.

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

The NDC (National Drug Code) for Ibuprofen and Pseudoephedrine Hydrochloride 200 mg/1 is 11822-0084, listed by Rite-Aid.

Product NDC

11822-0084

Package NDC

11822-0084-5

Other Ibuprofen 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)