![NAPROXEN SODIUM CAPSULE, LIQUID FILLED [SHOPKO STORES OPERATING CO., LLC.]](https://medic.hrt.org//dailymed/images/546c5de5-82c2-4fb0-9fe2-60f041c6c53d/naproxen-sodium-220-mg-softgel-delisted-1.jpg)
- Active ingredient (in each capsule)
- Purposes
- 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:
- 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
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, or kidney disease
- you are taking a diuretic
- you have problems or serious side effects from taking pain relievers or fever reducers
- you have asthma
Ask a doctor or pharmacist before use if you are
- under a doctor's care for any serious condition
- taking any other drug
When using this product
- take with food or milk if stomach upset occurs
- the risk of heart attack or stroke may increase if you use more than directed or for longer than directed
Stop use and ask a doctor if
- you experience any of the following signs of stomach bleeding:
- feel faint
- have bloody or black stools
- vomit blood
- have stomach pain that does not get better
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present in the painful area
- any new symptoms appear
- you have difficulty swallowing
- it feels like the capsule is stuck in your throat
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Directions
- do not take more than directed
- the smallest effective dose should be used
- drink a full glass of water with each dose
- if taken with food, this product may take longer to work
- adults and children 12 years and older:
- take 1 capsule every 8 to 12 hours while symptoms last
- for the first dose you may take 2 capsules within the first hour
- do not exceed 2 capsules in any 8- to 12-hour period
- do not exceed 3 capsules in a 24-hour period
- children under 12 years: ask a doctor
- Other information
- Inactive ingredients
- Questions or comments?
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Principal Display Panel
**Compare to the active ingredient of Aleve® Liquid Gels
Naproxen Sodium
Capsules, 220 mg (NSAID)
Pain Reliever / Fever Reducer
Strength to Last 12 Hours
Liquid Gels†
†(Liquid Filled Capsules)
**This product is not manufactured or distributed by Bayer HealthCare, LLC., owner of the registered trademark Aleve® Liquid Gels.
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
Packaged by: PL Developments
200 Hicks Street
Westbury, NY 11590, USA
©2014 Shopko Stores Operating Co., LLC
www.shopko.com
- Product Label
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INGREDIENTS AND APPEARANCE
NAPROXEN SODIUM
naproxen sodium capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37012-174 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN SODIUM 220 mg Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) LACTIC ACID (UNII: 33X04XA5AT) MANNITOL (UNII: 3OWL53L36A) POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9) POVIDONE K30 (UNII: U725QWY32X) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SORBITAN (UNII: 6O92ICV9RU) SORBITOL (UNII: 506T60A25R) Product Characteristics Color BLUE Score no score Shape CAPSULE Size 21mm Flavor Imprint Code NPX Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37012-174-40 1 in 1 BOX 12/31/2014 12/30/2021 1 40 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021920 12/31/2014 12/30/2021 Labeler - Shopko Stores Operating Co., LLC. (023252638)
