Label: GOOD SENSE ALL DAY PAIN RELIEF- naproxen sodium tablet
-
Contains inactivated NDC Code(s)
NDC Code(s): 33261-079-28, 33261-079-30, 33261-079-40 - Packager: Aidarex Pharmaceuticals LLC
- This is a repackaged label.
- Source NDC Code(s): 0113-9490
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated January 17, 2014
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- 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 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
- •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
-
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
- Inactive ingredients
- Questions or comments?
- Principal Display Panel
-
INGREDIENTS AND APPEARANCE
GOOD SENSE ALL DAY PAIN RELIEF
naproxen sodium tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:33261-079(NDC:0113-9490) 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 HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) POVIDONES (UNII: FZ989GH94E) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color BLUE (Light Blue) Score no score Shape ROUND Size 10mm Flavor Imprint Code L490 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:33261-079-28 28 in 1 BOTTLE, PLASTIC 2 NDC:33261-079-30 30 in 1 BOTTLE, PLASTIC 3 NDC:33261-079-40 40 in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA074661 01/14/1997 Labeler - Aidarex Pharmaceuticals LLC (801503249)
