Drugplain

Sinus and Cold D 220 mg/1

Naproxen sodium, Pseudoephedrine hydrochloride · TABLET, FILM COATED, EXTENDED RELEASE · CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED

No Recall History
Plain English

Sinus and Cold D is a tablet, film coated, extended release containing naproxen sodium, pseudoephedrine hydrochloride at 220 mg/1, taken oral. Manufactured by CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED.

Key Facts

Brand Name
Sinus and Cold D
Generic Name
Naproxen sodium, Pseudoephedrine hydrochloride
NDC Code (Product)
51316-339
Manufacturer
CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Strength
220 mg/1
Dosage Form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Marketing Status
Application #
ANDA076518
Marketing Start
05/08/2024

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

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. Do not use • 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 inhibi

Frequently Asked Questions

What is Sinus and Cold D used for?

Sinus and Cold D contains Naproxen sodium, Pseudoephedrine hydrochloride. It is a tablet, film coated, extended release taken oral. Consult your doctor for specific uses.

Is Sinus and Cold D a controlled substance?

Sinus and Cold D is not classified as a controlled substance by the DEA.

What is the generic name for Sinus and Cold D?

The generic name for Sinus and Cold D is Naproxen sodium, Pseudoephedrine hydrochloride. There are 1 other brand versions of Naproxen sodium, Pseudoephedrine hydrochloride.

What is the NDC code for Sinus and Cold D 220 mg/1?

The NDC (National Drug Code) for Sinus and Cold D 220 mg/1 is 51316-339, listed by CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED.

Product NDC

51316-339

Package NDC

51316-339-01

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

Data from openFDA · Public domain (CC0 1.0)