Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Cold 220 mg/1
Naproxen Sodium and Pseudoephedrine Hydrochloride · TABLET, EXTENDED RELEASE · Aurohealth LLC
Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Cold is a tablet, extended release containing naproxen sodium and pseudoephedrine hydrochloride at 220 mg/1, taken oral. Manufactured by Aurohealth LLC.
Key Facts
- Brand Name
- Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Cold
- Generic Name
- Naproxen Sodium and Pseudoephedrine Hydrochloride
- NDC Code (Product)
58602-816- Manufacturer
- Aurohealth LLC
- Strength
- 220 mg/1
- Dosage Form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA211360
- Marketing Start
- 06/01/2022
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
Uses temporarily relieves these cold, sinus, and flu symptoms: sinus pressure minor body aches and pains headache nasal and sinus congestion (promotes sinus drainage and restores freer breathing through the nose) fever
Dosage & Administration
Directions do not take more than directed the smallest effective dose should be used swallow whole; do not crush or chew drink a full glass of water with each dose adults and children 12 years and older: 1 caplet every 12 hours; do not take more than 2 caplets in 24 hours children under 12 years: do not use
Warnings
Warnings Allergy alert: Naproxen sodium 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 Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Cold used for?
Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Cold contains Naproxen Sodium and Pseudoephedrine Hydrochloride. It is a tablet, extended release taken oral. Consult your doctor for specific uses.
Is Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Cold a controlled substance?
Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Cold is not classified as a controlled substance by the DEA.
What is the generic name for Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Cold?
The generic name for Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Cold is Naproxen Sodium and Pseudoephedrine Hydrochloride. There are 3 other brand versions of Naproxen Sodium and Pseudoephedrine Hydrochloride.
What is the NDC code for Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Cold 220 mg/1?
The NDC (National Drug Code) for Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Cold 220 mg/1 is 58602-816, listed by Aurohealth LLC.