Congestion Relief

Congestion Relief is an FDA drug label for the active ingredient IBUPROFEN, PHENYLEPHRINE HCL manufactured by Meijer Distribution Inc administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20191205.

Generic: IBUPROFEN, PHENYLEPHRINE HCL

Manufacturer: Meijer Distribution Inc

Product Type: HUMAN OTC DRUG

Route: ORAL

Dosage Form:

NDC: 41250-158

Application: ANDA203200

Effective: 20191205

Active Ingredients: Active ingredients (in each tablet) Ibuprofen 200 mg (NSAID)* Phenylephrine HCl 10 mg *nonsteroidal anti-inflammatory drug

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 • reduces swelling of the nasal passages • temporarily restores freer breathing through the nose

Dosage & Administration

Directions • do not take more than directed • adults and children 12 years of age and over: • take 1 tablet every 4 hours while symptoms persist. • do not use more than 6 tablets in any 24-hour period unless directed by a doctor • children under 12 years of age: do not use because this product contains too much medication for children under this age

Contraindications

Not available.

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.

Adverse Reactions