ALEVE BACK AND MUSCLE PAIN- naproxen sodium tablet 
Bayer HealthCare LLC.

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Aleve Back & Muscle Pain UI 1600169

Drug Facts

Active ingredient (in each tablet)

Naproxen sodium 220 mg (naproxen 200 mg)

(NSAID)*

*nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/fever reducer

Uses

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

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

When using this product

  • take with food or milk if stomach upset occurs

Stop use and ask a doctor

  • 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
    • trouble breathing
    • weakness in one part or side of body
    • slurred speech
    • leg swelling

  • 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, ask a health professional before use. It is especially important not to use naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away

Directions

Adults and children 12 years and older
  • take 1 tablets 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 FD&C blue #2 lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide

Questions or comments? 1-800-395-0689 (Mon – Fri 9AM – 5PM EST)

Dist. by :

Bayer Healthcare LLC

Whippany, NJ 07981

Package label display

All Day Strong®

Aleve®

Back & Muscle Pain

naproxen sodium tablets, 220 mg (NSAID)

Pain reliever/fever reducer

Bayer

For temporary relief of minor back and muschle aches and pains

ACTUAL SIZE

Strength to Last 12 Hours 24Tablets

Aleve Back and Muscle 24 count carton

ALEVE BACK AND MUSCLE PAIN 
naproxen sodium tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-6092
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN SODIUM220 mg
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM STEARATE (UNII: 70097M6I30)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POVIDONE (UNII: FZ989GH94E)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
Product Characteristics
ColorblueScoreno score
ShapeROUNDSize8mm
FlavorImprint Code ALEVE
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0280-6092-241 in 1 CARTON01/26/2018
124 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:0280-6092-501 in 1 CARTON01/26/2018
250 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC:0280-6092-101 in 1 CARTON01/26/201809/30/2023
3100 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:0280-6092-251 in 1 CARTON08/06/2019
4250 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:0280-6092-021 in 1 CARTON01/26/2018
5130 in 1 BOTTLE; Type 0: Not a Combination Product
6NDC:0280-6092-041 in 1 CARTON01/26/2018
6200 in 1 BOTTLE; Type 0: Not a Combination Product
7NDC:0280-6092-051 in 1 CARTON01/26/2018
7225 in 1 BOTTLE; Type 0: Not a Combination Product
8NDC:0280-6092-061 in 1 CARTON01/26/201803/31/2022
836 in 1 BOTTLE; Type 0: Not a Combination Product
9NDC:0280-6092-071 in 1 CARTON01/26/201811/30/2021
965 in 1 BOTTLE; Type 0: Not a Combination Product
10NDC:0280-6092-081 in 1 CARTON07/01/2021
10250 in 1 BOTTLE; Type 0: Not a Combination Product
11NDC:0280-6092-091 in 1 CARTON07/01/2021
1190 in 1 BOTTLE; Type 0: Not a Combination Product
12NDC:0280-6092-1210 in 1 VIAL; Type 0: Not a Combination Product07/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02020401/26/2018
Labeler - Bayer HealthCare LLC. (112117283)

Revised: 11/2021
Document Id: d05ed230-209f-57d1-e053-2a95a90a1125
Set id: 6376e1b8-52c4-0519-e053-2a91aa0af35f
Version: 17
Effective Time: 20211109
 
Bayer HealthCare LLC.