Sinus and Cold D Naproxen sodium, Pseudoephedrine HCl NAPROXEN SODIUM NAPROXEN PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE SILICON DIOXIDE HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOLS POLYSORBATE 80 POVIDONES TALC TITANIUM DIOXIDE L417
Drug Facts
Composition & Profile
Identifiers & Packaging
Package/Label Principal Display Panel COMPARE TO active ingredients of ALEVE-D® SINUS & COLD See side panel Non-Drowsy Sinus & Cold-D Naproxen Sodium 220 mg and Pseudoephedrine Hydrochloride 120 mg Extended-Release Tablet Pain Reliever/Fever Reducer (NSAID) Nasal Decongestant 1 Caplet every 12 Hours 12 Hour Multi-Symptom Relief of Sinus Pressure Headache Sinus Congestion Nasal Congestion Body Aches Gluten Free Actual Size 20 CAPLETS** **Capsule-Shaped Tablets Kroger Sinus & Cold-D 1.jpg Kroger Sinus & Cold-D 2.jpg Kroger Sinus & Cold-D 3.jpg
- Package/Label Principal Display Panel COMPARE TO active ingredients of ALEVE-D® SINUS & COLD See side panel Non-Drowsy Sinus & Cold-D Naproxen Sodium 220 mg and Pseudoephedrine Hydrochloride 120 mg Extended-Release Tablet Pain Reliever/Fever Reducer (NSAID) Nasal Decongestant 1 Caplet every 12 Hours 12 Hour Multi-Symptom Relief of Sinus Pressure Headache Sinus Congestion Nasal Congestion Body Aches Gluten Free Actual Size 20 CAPLETS** **Capsule-Shaped Tablets Kroger Sinus & Cold-D 1.jpg Kroger Sinus & Cold-D 2.jpg Kroger Sinus & Cold-D 3.jpg
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 • 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 22 mg • store at 20-25°C (68-77°F) • store in a dry place
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 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 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 • 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, or kidney disease • you are taking a diuretic • you have problems or serious side effects from taking pain relievers or fever reducers • you have • asthma • diabetes • thyroid disease • trouble urinating due to an enlarged prostate gland 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 • 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 experience any of the following signs of stomach bleeding: • feel faint • vomit blood • have bloody or black stools • have stomach pain that does not get better • redness or swelling is present in the painful area • any new symptoms appear • fever gets worse or lasts more than 3 days • you have difficulty swallowing or the caplet feels stuck in your throat • 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.
Purpose
Purposes Pain reliever/fever reducer 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 experience any of the following signs of stomach bleeding: • feel faint • vomit blood • have bloody or black stools • have stomach pain that does not get better • redness or swelling is present in the painful area • any new symptoms appear • fever gets worse or lasts more than 3 days • you have difficulty swallowing or the caplet feels stuck in your throat • 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 22 mg • store at 20-25°C (68-77°F) • store in a dry place
Questions
Questions or comments? 1-800-632-6900
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