![NAPROXEN SODIUM CAPSULE, LIQUID FILLED [THE KROGER CO.]](https://medic.hrt.org//dailymed/images/5f945b8f-e1b8-452a-a013-9e32bf7df666/naproxen-sodium-220-mg-softgels-ban-delisted-1.jpg)
- Active ingredient (in each capsule)
- Purposes
- Uses
-
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
- have 3 or more alcoholic drinks every day while using this product
- take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
- take more or for a longer time than directed
Heart attack and stroke: 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
- have bloody or black stools
- vomit blood
- have stomach pain that does not get better
- you have symptoms of heart problems or stroke:
- chest pain
- slurred speech
- leg swelling
- trouble breathing
- weakness in one part of the body
- 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 appea
- you have difficulty swallowing
- it feels like the capsule is stuck in your throat
-
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?
-
Principal Display Panel
COMPARE TO active ingredient of ALEVE®
***See back panel
THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN
EASY OPEN CAP
Naproxen Sodium
Capsules, 220 mg (NSAID)
Pain Reliever/ Fever Reducer
STRENGTH TO LAST
12 HOURS
CAPSULES**
(**liquid-filled capsules)
***Aleve® is a registered trademark of Bayer HealthCare LLC, Morristown, NJ 07960. Bayer HealthCare LLC is not affiliated with The Kroger Co. or this product.
GLUTEN FREE
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
DISTRIBUTED BY THE KROGER CO.
CINCINNATI, OHIO 45202
- Product Label
-
INGREDIENTS AND APPEARANCE
NAPROXEN SODIUM
naproxen sodium capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:30142-174 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) POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) LACTIC ACID (UNII: 33X04XA5AT) MANNITOL (UNII: 3OWL53L36A) 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 12mm Flavor Imprint Code NPX Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:30142-174-16 1 in 1 BOX 10/31/2014 02/23/2024 1 160 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:30142-174-30 1 in 1 BOX 10/31/2014 02/23/2024 2 30 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:30142-174-80 80 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/31/2014 02/23/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021920 10/31/2014 02/23/2024 Labeler - The Kroger Co. (006999528)
