VICKS® Sinex™ D Severe Sinus & Cold
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredients (in each caplet)
Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* Pseudoephedrine HCl 120 mg, extended-release *nonsteroidal anti-inflammatory drug
Purpose
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 breathing through the nose)
- fever
Warnings
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.
- hives
- facial swelling
- asthma (wheezing)
- shock
- skin reddening
- rash
- blisters
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 usemore than directed or for longer than directed.
Do not use
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.
- 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
Ask a doctor before use if you
urinating due to an enlarged prostate gland, or had a stroke
- the stomach bleeding warning applies to you
- you have a history of stomach problems, such as heartburn
- you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, thyroid disease, diabetes, have trouble
Ask a doctor or pharmacist before use if you are
- under a doctor's care for any serious condition
- taking any other drug
When using this product
- take with food or milk if stomach upset occurs
Stop use and ask a doctor if
you experience any of the following signs of stomach bleeding:
chest pain
trouble breathing
weakness in one part or side of body
slurred speech
leg swelling
- feel faint
- vomit blood
- have bloody or black stools
- have stomach pain that does not get better
- you have symptoms of heart problems or stroke:
OTC - PREGNANCY OR BREAST FEEDING SECTION
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.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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).
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
Other information
- each caplet contains: sodium 21 mg
- 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
SPL UNCLASSIFIED SECTION
Dist. by Procter & Gamble, Cincinnati OH 45202