Sudafed Sinus and Pain 12 Hour Naproxen Sodium and Pseudoephedrine hydrochloride Naproxen Sodium Naproxen Pseudoephedrine hydrochloride Pseudoephedrine silicon dioxide hypromelloses lactose monohydrate magnesium stearate cellulose, microcrystalline polyethylene glycols polysorbate 80 povidones talc titanium dioxide Film-coated SUDAFED
Drug Facts
Composition & Profile
Identifiers & Packaging
PRINCIPAL DISPLAY PANEL NDC 50580-358-16 Non-Drowsy SUDAFED ® Sinus & Pain 12 Hour Naproxen Sodium 220 mg (NSAID) Pseudoephedrine HCl 120 mg extended-release tablet Pain Reliever/Fever Reducer, Nasal Decongestant → Headache NAPROXEN SODIUM → Sinus Pressure & Congestion PSEUDOEPHEDRINE HCL 16 Caplets* (1 Caplet / 12 Hours) (actual size) *Capsule-Shaped Tablets Principal Display Panel
- PRINCIPAL DISPLAY PANEL NDC 50580-358-16 Non-Drowsy SUDAFED ® Sinus & Pain 12 Hour Naproxen Sodium 220 mg (NSAID) Pseudoephedrine HCl 120 mg extended-release tablet Pain Reliever/Fever Reducer, Nasal Decongestant → Headache NAPROXEN SODIUM → Sinus Pressure & Congestion PSEUDOEPHEDRINE HCL 16 Caplets* (1 Caplet / 12 Hours) (actual size) *Capsule-Shaped Tablets Principal Display Panel
Overview
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
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 do not take longer than 7 days, unless directed by a doctor (see Warnings ) 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 & Precautions
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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause 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 an NSAID (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 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 inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. in children under 12 years of age Ask a doctor before use if you have problems or serious side effects from taking pain relievers or fever reducers stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain ulcers asthma bleeding problems high blood pressure heart or kidney disease taken a diuretic reached age 60 or older thyroid disease diabetes trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking any other drug containing an NSAID (prescription or nonprescription) taking a blood thinning (anticoagulant) or steroid drug under a doctor's care for any serious condition using any other product that contains naproxen or pseudoephedrine taking any other pain reliever/fever reducer or nasal decongestant taking any other drug When using this product take with food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or for longer than directed Stop use and ask a doctor if you feel faint, vomit blood, or have bloody or black stools. These are signs of stomach bleeding. fever gets worse or lasts more than 3 days stomach pain or upset gets worse or lasts redness or swelling is present in the painful area any new symptoms appear you have difficulty swallowing or the caplet feels stuck in your throat you develop heartburn you get nervous, dizzy, or sleepless nasal congestion lasts more than 7 days If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Purpose
Active ingredients (in each caplet) Purposes Naproxen sodium 220 mg (naproxen 200 mg) (NSAID) nonsteroidal anti-inflammatory drug Pain reliever/ fever reducer Pseudoephedrine HCl 120 mg, extended-release Nasal decongestant
Do Not Use
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 inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. in children under 12 years of age
When Using
When using this product take with food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or for longer than directed
Stop Use & Ask a Doctor
Stop use and ask a doctor if you feel faint, vomit blood, or have bloody or black stools. These are signs of stomach bleeding. fever gets worse or lasts more than 3 days stomach pain or upset gets worse or lasts redness or swelling is present in the painful area any new symptoms appear you have difficulty swallowing or the caplet feels stuck in your throat you develop heartburn you get nervous, dizzy, or sleepless nasal congestion lasts more than 7 days
Keep Out of Reach of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Storage & Handling
Other information each caplet contains: sodium 20 mg store at 20-25°C (68-77°F) store in a dry place
Questions
Questions or comments? 1-888-217-2117
Similar Drugs
Related medications based on brand, generic name, substance, active ingredients.