BAYER ALEVE- naproxen sodium tablet 
Unifirst First Aid Corporation

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Bayer Aleve

Drug Facts

Active ingredient (in each caplet)

Naproxen Sodium 220 mg (naproxen 200 mg) (NSAID)*

*nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/fever reducer

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 stomach ulcers or bleeding problems
take a blood thinner (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: NSAID,s 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

Ask a doctor before use if

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding,

ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless specifically 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 accidental overdose, get medical help or contact a Poison Control Center right away.

Directions

Adults and children: (12 years and older)

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)

All Day Strong

Aleve

naproxen sodium tablets, 220 mg (NSAID)

Pain reliever/fever reducer

Pull To Open

Bayer

Strength To Last 12 Hours

50 Caplets

Capsule-Shaped Tablets, 1 /PKT

Bayer

BAYER ALEVE 
naproxen sodium tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-488
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
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Colorblue (blue) Scoreno score
ShapeOVAL (OVAL) Size14mm
FlavorImprint Code ALEVE
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:47682-488-5050 in 1 BOX01/24/2014
11 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02020401/24/2014
Labeler - Unifirst First Aid Corporation (832947092)
Registrant - Unifirst First Aid Corporation (832947092)
Establishment
NameAddressID/FEIBusiness Operations
Bayer Healthcare LLC072827066manufacture(47682-488)

Revised: 5/2022
Document Id: de496a74-9215-1576-e053-2a95a90a14c7
Set id: 5dd569ca-d03e-410c-af98-4732c823d595
Version: 8
Effective Time: 20220505
 
Unifirst First Aid Corporation