Active Ingredients And Purpose
Active ingredient (in each caplet)
Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* *nonsteroidal anti-inflammatory drug
Purposes
Pain reliever/fever reducer
Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* *nonsteroidal anti-inflammatory drug
Pain reliever/fever reducer
• temporarily relieves minor aches and pains due to: • minor pain of arthritis • muscular aches • backache • menstrual cramps • headache • toothache • the common cold • temporarily reduces fever
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 take more than directed • the smallest effective dose should be used • drink a full glass of water with each dose Adults and children 12 years and older • take 1 caplet every 8 to 12 hours while symptoms last • for the first dose you may take 2 caplets within the first hour • do not exceed 2 caplets in any 8- to 12-hour period • do not exceed 3 caplets in a 24-hour period Children under 12 years • ask a doctor
• each caplet contains: sodium 22 mg • store at 20-25°C (68-77°F). Avoid high humidity and excessive heat above 40°C (104°F).
FD&C blue no. 2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide
1-800-719-9260
Compare to Aleve ® active ingredient Signature care ® Quality Guaranteed Naproxen Sodium TABLETS, 220 mg Pain Reliever/Fever Reducer (NSAID) Strength to last 12 hours Actual Size 90 CAPLETS** **Capsule-Shaped Tablets
Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* *nonsteroidal anti-inflammatory drug
Pain reliever/fever reducer
• temporarily relieves minor aches and pains due to: • minor pain of arthritis • muscular aches • backache • menstrual cramps • headache • toothache • the common cold • temporarily reduces fever
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 take more than directed • the smallest effective dose should be used • drink a full glass of water with each dose Adults and children 12 years and older • take 1 caplet every 8 to 12 hours while symptoms last • for the first dose you may take 2 caplets within the first hour • do not exceed 2 caplets in any 8- to 12-hour period • do not exceed 3 caplets in a 24-hour period Children under 12 years • ask a doctor
• each caplet contains: sodium 22 mg • store at 20-25°C (68-77°F). Avoid high humidity and excessive heat above 40°C (104°F).
FD&C blue no. 2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide
1-800-719-9260
Compare to Aleve ® active ingredient Signature care ® Quality Guaranteed Naproxen Sodium TABLETS, 220 mg Pain Reliever/Fever Reducer (NSAID) Strength to last 12 hours Actual Size 90 CAPLETS** **Capsule-Shaped Tablets
Official SPL XML cached by FDA.report · DailyMed PDF
| Folder | File | Date |
|---|---|---|
| otc | 347809fc-ce5e-49ff-b4e5-a36aa9eb6a72.xml | 2025-12-17 |
| otc | 6bf6778a-0516-4cf4-8542-3249feea88e5.xml | 2025-03-08 |
| otc | signature-care-naproxen-sodium-carton-image.jpg | 2025-03-08 |
| otc | 2b1d2ad6-0214-4af4-aa70-47c3b14e6faf.xml | 2022-04-28 |
| otc | b11dea07-85f8-4631-bdd4-2058d284874d.xml | 2021-12-02 |
| otc | image-01.jpg | 2021-12-02 |
| otc | 9f1bc7f6-a4a0-4350-ba71-e66fd13ef160.xml | 2019-12-17 |
| otc | 368 LJ naproxen-sodium-image.jpg | 2018-05-01 |
| otc | 85f78e63-98aa-4cf3-887d-0ac535184f97.xml | 2018-05-01 |