Label: TOPCARE SINUS AND COLD D- naproxen sodium, pseudoephedrine hcl tablet, film coated, extended release

  • NDC Code(s): 36800-417-01, 36800-417-52
  • Packager: Topco Associates LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 17, 2025

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  • Active ingredients (in each caplet)
    Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* Pseudoephedrine HCl 120 mg, extended-release - *nonsteroidal anti-inflammatory drug
  • Purposes
    Pain reliever/fever reducer - Nasal decongestant
  • 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 ...
  • 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 ...
  • 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 ...
  • Other information
    • each caplet contains: sodium 21 mg - • FDA approved dissolution specification differs from the USP dissolution specification - • store at 20-25°C (68-77°F) • store in a dry place
  • Inactive ingredients
    colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, talc, titanium dioxide
  • Questions or comments?
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  • Package/Label Principal Display Panel
    TopCare® health - COMPARE TO ALEVE-D® SINUS & COLD ACTIVE INGREDIENTS - NON-DROWSY - Sinus & Cold-D - NAPROXEN SODIUM 220 mg - PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg - EXTENDED-RELEASE TABLET - PAIN ...
  • INGREDIENTS AND APPEARANCE
    Product Information