Naproxen Sodium by CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED / LNK International, Inc. CVS 44-417 HP-Delisted
Naproxen Sodium by
Drug Labeling and Warnings
Naproxen Sodium by is a Otc medication manufactured, distributed, or labeled by CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED, LNK International, Inc.. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
NAPROXEN SODIUM- naproxen sodium tablet, film coated
CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
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CVS 44-417 HP-Delisted
Active ingredient (in each tablet)
Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)*
*nonsteroidal anti-inflammatory drug
Uses
- temporarily relieves minor aches and pains due to:
- headache
- muscular aches
- the common cold
- toothache
- backache
- menstrual cramps
- minor pain of arthritis
- temporarily reduces fever
Warnings
Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
- asthma (wheezing)
- skin reddening
- shock
- blisters
- rash
- facial swelling
- hives
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
Ask a doctor before use if
- the stomach bleeding warning applies to you
- you have a history of stomach problems, such as heartburn
- you are taking a diuretic
- you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
- 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
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:
- leg swelling
- chest pain
- slurred speech
- trouble breathing
- weakness in one part or side of body
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- you have difficulty swallowing
- it feels like the pill is stuck in your throat
- redness or swelling is present in the painful area
- any new symptoms appear
Directions
- 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 tablet every 8 to 12 hours while symptoms last
- for the first dose you may take 2 tablets within the first hour
- do not exceed 2 tablets in any 8- to 12-hour period
- do not exceed 3 tablets in a 24-hour period
- children under 12 years: ask a doctor
Other information
- each tablet contains: sodium 20 mg
- store at 20°-25°C (68°-77°F). Avoid high humidity and excessive heat above 40°C (104°F)
- see end flap for expiration date and lot number
Inactive ingredients
croscarmellose sodium, FD&C blue #2 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, talc, titanium dioxide
Principal display panel
CVSHealth®
Compare to the active ingredient
in Aleve® Headache Pain Tablets†
Tablets
Naproxen
Sodium
TABLETS, 220 mg
Pain reliever,
Fever reducer
(NSAID)
STRENGTH
TO LAST
12
HOURS
HEADACHE
PAIN
For temporary relief
of minor headache
pain
Actual Size
50 TABLETS
TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
†This product is not manufactured or distributed
by Bayer HealthCare LLC, owner of the registered
trademark Aleve® Headache Pain Tablets.
50844 ORG052041715
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
©2022 CVS/pharmacy
CVS.com® 1-800-SHOP CVS V-11112
CVS® Quality
Money Back Guarantee
CVS Health 44-417 ORG0520
| NAPROXEN SODIUM
naproxen sodium tablet, film coated |
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| Labeler - CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED (062312574) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LNK International, Inc. | 038154464 | pack(51316-417) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LNK International, Inc. | 832867837 | manufacture(51316-417) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LNK International, Inc. | 832867894 | manufacture(51316-417) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LNK International, Inc. | 967626305 | pack(51316-417) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LNK International, Inc. | 117025878 | manufacture(51316-417) | |
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