BACK AND MUSCLE PAIN- naproxen tablet, coated 
WALGREENS

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609R WALGREENS BACK AND MUSCLE ALL DAY PAIN RELIEF NDC 0363-9609-42 & (01)- NAPROXEN

DRUG FACTS

ACTIVE INGREDIENT

Naproxen Sodium 220 mg
(naproxen 200 mg)(NSAID)*
*nonsteroidal anti-inflammatory drug

PURPOSE

Purposes

Pain reliever/ fever reducer

Uses

temporarily relieves minor aches and pain due to:

  • minor pain of arthritis
  • muscular aches
  • backache
  • menstrual cramps
  • headache
  • toothache
  • the common cold

temporarily reduces fever

Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
asthma (wheezing)
blisters
facial swelling
hives
rash
shock
skin reddening
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 bad 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: NSAID's, except aspirin, increases 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 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
  • 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 at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

In case of overdose, get medical help or contact a poison control center right away.

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 to12 hours while symptoms last
for first dose you may take 2 tablets with in 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

each tablet contains: sodium 20 mg

store at 20-25ºC (68-77ºF).

Avoid high humidity and excessive heat above 40°C (104°F).

INACTIVE INGREDIENTS

Colloidal silicon dioxide, croscarmellose sodium, FD&C blue #2 lake, Hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide.

call 1-877-290-4008

24 CT

Naproxen-220mg- walgreens-24s tab-carton

100 CT

Naproxen-220mg- walgreens-100s tab-carton

90 CT

609R-WG-90s-label609R-WG-90s-ifc

BACK AND MUSCLE PAIN 
naproxen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-9609
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorblueScoreno score
ShapeROUNDSize10mm
FlavorImprint Code 141
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-9609-4224 in 1 BOTTLE; Type 0: Not a Combination Product06/05/2019
2NDC:0363-9609-01100 in 1 BOTTLE; Type 0: Not a Combination Product06/03/2019
3NDC:0363-9609-091 in 1 CARTON06/26/2021
390 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09054506/03/2019
Labeler - WALGREENS (008965063)
Registrant - TIME CAP LABORATORIES, INC (037052099)
Establishment
NameAddressID/FEIBusiness Operations
MARKSANS PHARMA LTD925822975manufacture(0363-9609)

Revised: 4/2023
 
WALGREENS