Label: ALL DAY PAIN RELIEF- naproxen sodium tablet
- NDC Code(s): 55315-168-01, 55315-168-24, 55315-168-50
- Packager: Freds Inc
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated October 19, 2021
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- 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
- 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
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 have problems or serious side effects from taking pain relievers or fever reducers
- you have asthma
- 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
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 pill 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
- 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?
-
Principal Display Panel
All Day Pain Relief
Naproxen Sodium Tablets, 220 mg
Pain Reliever / Fever Reducer (NSAID)
CAPLETS**
(**Capsule-Shaped Tablets)
220 mg each
Compare to the active ingredient in Aleve®†
†This product is not manufactured or distributed by Bayer HealthCare, LLC., owner of the registered trademark Aleve®.
DO NOT USE IF INNER SEAL UNDER BOTTLE CAP PRINTED WITH "SEALED FOR YOUR PROTECTION" IS BROKEN OR MISSING
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
DISTRIBUTED BY: FRED'S INC.
4300 NEW GETWELL RD, MEMPHIS, TN 38118
- Product Label
-
INGREDIENTS AND APPEARANCE
ALL DAY PAIN RELIEF
naproxen sodium tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55315-168 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 GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) POVIDONE (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color blue Score no score Shape CAPSULE Size 12mm Flavor Imprint Code 17 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55315-168-50 1 in 1 BOX 09/30/2015 04/26/2024 1 50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:55315-168-01 1 in 1 BOX 09/30/2015 04/26/2024 2 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 3 NDC:55315-168-24 1 in 1 BOX 09/30/2015 04/26/2024 3 24 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 ANDA ANDA079096 09/30/2015 04/26/2024 Labeler - Freds Inc (005866116)
