Leader All Day Sinus and Cold D Naproxen sodium, Pseudoephedrine HCl 220 mg; 120 mg Tablet, Film Coated, Extended Release
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Nonsteroidal Anti-inflammatory Drug class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Prescription naproxen is used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints), rheumatoid arthritis (arthritis caused by swelling of the lining of the joints), juvenile arthritis (a form of joint disease in children), and ankylosing spondylitis (arthritis that mainly affects the spine). Prescription naproxen tablets, extended-release tablets, and suspension are also used to relieve shoulder pain caused by bursitis (inflammation of a fluid-filled sac in the shoulder joint), tendinitis (inflammation of th...
Read the full MedlinePlus article ↗Patient education
Supplement & herbal interactions
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Where does this data come from?
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
-
UNII EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
-
UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
-
UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
-
UNII 3WJQ0SDW1A
Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
-
UNII 6OZP39ZG8H
Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
-
UNII FZ989GH94E
Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
-
UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
-
UNII 7SEV7J4R1U
A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
-
UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
10 inactive ingredients listed in the exact product block matched to this NDC.
Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.244 | $4.89 / 20 tablet |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Leader All Day Sinus and Cold D 220 mg/1; 120 mgthis 70000-0605-01 | Cardinal | 1 tablet | $0.244 | — | Availability likely | — |
| Aleve-D Sinus and Headache 220 mg/1; 120 mg 00280-6045-10 | Bayer | 10 tablets | — | — | FDA listed | — |
| Aleve-D Sinus and Cold 120 mg/1; 220 mg 00280-6090-10 | Bayer | 10 tablets | — | — | FDA listed | — |
| All Day Sinus and Cold D 220 mg/1; 120 mg 00363-0650-01 | Walgreen | 1 tablet | — | — | FDA listed | — |
| Topcare Sinus and Cold D 220 mg/1; 120 mg 36800-0417-01 | Topco | 1 tablet | — | — | FDA listed | — |
| Sinus and Cold D 220 mg/1; 120 mg 41250-0417-01 | Meijer | 1 tablet | — | — | FDA listed | — |
| Sudafed Sinus 12 Hour Pressure plus Pain 220 mg/1; 120 mg 50580-0434-01 | Kenvue | 8 tablets | — | — | FDA listed | — |
| Sinus and Cold D 220 mg/1; 120 mg 51316-0339-01 | CVS | 1 tablet | — | — | FDA listed | — |
| Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Cold 220 mg/1; 120 mg 58602-0816-67 | Aurohealth | 10 tablets | — | — | FDA listed | — |
| Naproxen Sodium and Pseudoephedrine Hydrochloride Sinus and Headache 220 mg/1; 120 mg 58602-0832-67 | Aurohealth | 10 tablets | — | — | FDA listed | — |
| Naproxen Sodium And Pseudoephedrine Hydrochloride Cold And Sinus 220 mg/1; 120 mg 71179-0816-24 | VESPYR | 8 tablets | — | — | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 70000-0605-01 You're viewing this | 20 BLISTER PACK in 1 CARTON (70000-0605-1) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | 2022-05-19 | Active |
📄 FDA label — Drug Facts FDA SPL
🎯 Indications and 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 and 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
⚠️ Warnings ▾
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 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.
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, kidney disease, asthma, thyroid disease, diabetes, have trouble urinating due to an enlarged prostate gland, or had a stroke • you are taking a diuretic • you have problems or serious side effects from taking pain relievers or fever reducers Ask a doctor or pharmacist before use if you are • under a doctor’s care for any serious condition • taking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin • 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: • 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: • chest pain • trouble breathing • weakness in one part or side of body • slurred speech • leg swelling • 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 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. 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 and Handling ▾
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
🧪 Active Ingredient ▾
Active ingredients (in each caplet) Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* Pseudoephedrine HCl 120 mg, extended-release *nonsteroidal anti-inflammatory drug
🧪 Inactive Ingredients ▾
Inactive ingredients colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, talc, titanium dioxide
🎯 Purpose ▾
Purposes Pain reliever/fever reducer Nasal decongestant