Active Ingredients (In Each Caplet)
Naproxen sodium USP 220 mg (naproxen 200 mg) (NSAID)*
Pseudoephedrine Hydrochloride USP 120 mg, extended-release
*nonsteroidal anti-inflammatory drug
The following Structured Product Label (SPL) was submitted to the FDA by Vespyr Brands Llc for the product Naproxen Sodium And Pseudoephedrine Hydrochloride Cold And Sinus (NDC 71179-816). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients (in each caplet), purposes, uses, warnings, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Naproxen sodium USP 220 mg (naproxen 200 mg) (NSAID)*
Pseudoephedrine Hydrochloride USP 120 mg, extended-release
*nonsteroidal anti-inflammatory drug
Pain reliever/fever reducer
Nasal decongestant
temporarily relieves these cold, sinus, and flu symptoms:
Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
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:
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.
ask a health professional before use. It is especially important not to use naproxen sodium at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Colloidal silicon dioxide, croscarmellose sodium, ferric oxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc and titanium dioxide.
call 1 (855) 874-0970 (Monday – Friday 8A to 5P EST)
DISTRIBUTED BY:
Vespyr Brands®, LLC.,
East Windsor NJ 08520
© 2024 Vespyr Brands®, LLC.
All rights reserved
Contac® is a registered trademark
of Vespyr Brands®, LLC.
www.contac.com
Made in India
NDC 71179-816-24
12
HOUR
CONTAC-D™
COLD & SINUS
Naproxen Sodium 220 mg
& Pseudoephedrine HCL 120 mg
Pain Reliever/Fever Reducer (NSAID)
& Nasal Decongestant
MAXIMUM STRENGTH
24 EXTENDED-RELEASE CAPLETS
* Please review the disclaimer below.