Active Ingredients (In Each Caplet)
Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)*
Pseudoephedrine HCl 120 mg, extended-release
*nonsteroidal anti-inflammatory drug
The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health 110, Llc. Dba Leader for the product Leader All Day Sinus And Cold D (NDC 70000-0605). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients (in each caplet), purposes, uses, warnings, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)*
Pseudoephedrine HCl 120 mg, extended-release
*nonsteroidal anti-inflammatory drug
Pain reliever/fever reducer
Nasal decongestant
temporarily relieves these cold, sinus, and flu symptoms:
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.
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
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.
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.
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, talc, titanium dioxide
1-800-719-9260
LEADER™
Non-Drowsy
All Day Sinus & Cold-D
Naproxen Sodium, 220 mg
Pseudoephedrine Hydrochloride, 120 mg
Extended-Release Tablet
Pain Reliever/Fever Reducer (NSAID) | Nasal Decongestant
12-Hour Multi-Symptom Relief of:
Sinus Pressure, Headache, Sinus Congestion, Nasal Congestion & Body Aches
1 Caplet – 12 Hours
Actual Size
COMPARE TO ALEVE-D® SINUS & COLD active ingredients
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20 CAPLETS**
**Capsule-Shaped Tablets
* Please review the disclaimer below.