![NAPROXEN SODIUM TABLET, FILM COATED [WAL-MART STORES INC]](https://medic.hrt.org//dailymed/images/34157517-3caf-4b95-9e2c-dfe2bc51066e/equate-44-604---delisted-1.jpg)
- Active ingredient (in each caplet)
- Purpose
- Uses
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Warnings
Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
- blisters
- shock
- rash
- hives
- asthma (wheezing)
- skin reddening
- facial swelling
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]
- take more or for a longer time than directed
- have 3 or more alcoholic drinks every day while using this product
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 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
- you are taking a diuretic
Ask a doctor or pharmacist before use if you are
- under a doctor’s care for any serious condition
- 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
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Directions
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do not take more than directed
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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
- take 1 caplet every 8 to 12 hours while symptoms last
- children under 12 years: ask a doctor
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do not take more than directed
- Other information
- Inactive ingredients
- Questions or comments?
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Principal display panel
equate™
EASY OPEN CAP
NDC 49035-903-12
Compare to Aleve® Caplets Active Ingredient**
Naproxen
Sodium
Tablets, 220 mg
Pain Reliever/Fever Reducer (NSAID)
Strength to Last 12 Hours
NOT FOR HOUSEHOLDS WITH YOUNG CHILDREN
12
HOUR
RELIEF220
mg EACH100
CAPLETS†Actual Size
†Capsule-Shaped Tablets
100Satisfaction guaranteed – For questions or comments please call 1-888-287-1915.
DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716
PRODUCT OF CHINA**This product is not manufactured or distributed by Bayer HealthCare LLC, owner of
the registered trademark Aleve® Caplets.50844 ORG051760412 729665
Equate 44-404
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INGREDIENTS AND APPEARANCE
NAPROXEN SODIUM
naproxen sodium tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-903 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 2-NAPHTHALENEACETIC ACID, 6-METHOXY-.ALPHA.-METHYL-, SODIUM SALT, (S)- (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ) 2-NAPHTHALENEACETIC ACID, 6-METHOXY-.ALPHA.-METHYL-, SODIUM SALT, (S)- 220 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C BLUE NO. 2--ALUMINUM LAKE (UNII: 4AQJ3LG584) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color blue Score no score Shape OVAL Size 12mm Flavor Imprint Code 44;604 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49035-903-10 1 in 1 CARTON 01/23/2017 02/09/2023 1 40 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:49035-903-12 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/23/2017 02/09/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA204872 01/23/2017 02/09/2023 Labeler - Wal-Mart Stores Inc (051957769) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 manufacture(49035-903) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 pack(49035-903) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 pack(49035-903) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 pack(49035-903) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 pack(49035-903)