Label: ALL DAY BACK AND MUSCLE PAIN RELIEF- naproxen sodium tablet, film coated
- NDC Code(s): 79903-098-06, 79903-098-52
- Packager: WALMART INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated September 21, 2023
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:
- asthma (wheezing)
- skin reddening
- shock
- blisters
- rash
- facial swelling
- hives
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
- have had stomach ulcers or bleeding problems
- take a blood thinning (anticoagulant) or steroid drug
- are age 60 or older
- 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
Heart attack and stroke warning: 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 are taking a diuretic
- you have problems or serious side effects from taking pain relievers or fever reducers
Ask a doctor or pharmacist before use if you are
- under a doctor’s care for any serious condition
- taking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin
- taking any other drug
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
- you have symptoms of heart problems or stroke:
- chest pain
- slurred speech
- leg swelling
- trouble breathing
- weakness in one part or side of body
- 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
- take 1 tablet every 8 to 12 hours while symptoms last
- children under 12 years: ask a doctor
-
do not take more than directed
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal display panel
equate™
NDC 79903-098-52
Compare to
Aleve® Back &
Muscle Pain
Tablets active
ingredient**All Day
Back & Muscle
Pain ReliefNaproxen Sodium
Tablets, 220 mgPain Reliever/
Fever Reducer
(NSAID)• For temporary relief of minor
back and muscle aches and painsActual Size
STRENGTH TO LAST
12 HOURS220
mg
EACH
90 TABLETS
Satisfaction guaranteed - Or
we'll replace it or give you your
money back. For questions or
comments or to report an
undesired reaction or side effect,
please call 1-888-287-1915.DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716
PRODUCT OF CHINA AND INDIA
**This product is not manufactured or distributed by Bayer
HealthCare LLC, owner of the registered trademark Aleve®
Back & Muscle Pain Tablets.50844 REV1221A41752
TAMPER EVIDENT: DO NOT USE IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Equate 44-417BM
-
INGREDIENTS AND APPEARANCE
ALL DAY BACK AND MUSCLE PAIN RELIEF
naproxen sodium tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79903-098 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--ALUMINUM LAKE (UNII: 4AQJ3LG584) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color blue Score no score Shape ROUND Size 10mm Flavor Imprint Code 44;417 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79903-098-06 1 in 1 CARTON 01/17/2022 1 200 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:79903-098-52 1 in 1 CARTON 01/17/2022 2 90 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 ANDA204872 01/17/2022 Labeler - WALMART INC. (051957769) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 pack(79903-098) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 manufacture(79903-098) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 manufacture(79903-098) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 pack(79903-098) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 117025878 manufacture(79903-098)