- Active ingredient (in each caplet)
- 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
- take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
- have 3 or more alcoholic drinks everyday while using this product
- take more or for a longer time than directed
- Do not use
-
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
- When using this product
-
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
- 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
- If pregnant or breast-feeding
- Keep out of reach of children
-
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 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
- Other Information
- Inactive Ingredients:
- Questions or comments? 1-877-586-7979
-
PRINCIPAL DISPLAY PANEL - 220 mg TABLET CARTON
Preferred Plus Pharmacy
NDC 61715-060-50
SEE NEW WARNINGS INFORMATION
*Compare to the Active Ingredient in Aleve®
Naproxen Sodium Tablets, USP 220 mg
Pain Reliever/Fever Reducer (NSAID)
50 COATED CAPLETS†
†CAPSULE-SHAPED TABLETS
Distributed By:
Kinray, Inc., Whitestone, NY 11357
(c) 2013 Kinray Inc., All Rights Reserved, PREFERRED PLUS, PREFERRED PLUS ++++ and the PREFERRED PLUS logo are trademarks and/or registered trademarks of Kinray Inc. All other marks are property of their respective owners.
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INGREDIENTS AND APPEARANCE
NAPROXEN SODIUM
naproxen sodium tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61715-060 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 CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYVINYL ALCOHOL (UNII: 532B59J990) POVIDONE (UNII: FZ989GH94E) STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color blue Score no score Shape OVAL (Capsule-Shaped) Size 12mm Flavor Imprint Code 17 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61715-060-50 1 in 1 CARTON 1 50 in 1 BOTTLE, PLASTIC 2 NDC:61715-060-51 1 in 1 CARTON 2 100 in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA079096 11/25/2009 Labeler - Kinray (012574513) Registrant - Aphena Pharma Solutions - Kentucky, LLC (557054835) Establishment Name Address ID/FEI Business Operations Aphena Pharma Solutions - Kentucky, LLC 557054835 repack(61715-060) Establishment Name Address ID/FEI Business Operations Amneal Pharmaceuticals 831227801 manufacture(61715-060)