ALL DAY PAIN RELIEF- naproxen sodium tablet, coated 
WALGREENS

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608R WALGREEN 0363-9608 NAPROXEN SODIUM CAPLETS ALL DAY PAIN RELIEF

DRUG FACTS

Naproxen Sodium 220 mg

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

Pain reliever/Fever reducer

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

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 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

Ask a doctor before use if

Ask a doctor or pharmacist before use if you are

When using this product

take with food or milk if stomach upset occurs

Stop use and ask a doctor if

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

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.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away(1-800-222-1222).

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 cablet every 8 to12 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

each caplet contains: sodium 20 mg
store at 20-25ºC (68-77ºF).

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

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

Questions or comments?call 1-877-290-4008

naproxen-90-labelnaproxen-90-ez-labelnaproxen-600-labelnaproxen-90s-cartonnaproxen-24s-cartonnaproxen-24-label608R-WG-50s-label608R-WG-50s-ifc608R-WG-270s-label

ALL DAY PAIN RELIEF 
naproxen sodium tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-9608
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
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
FD&C BLUE NO. 2--ALUMINUM LAKE (UNII: 4AQJ3LG584)  
Product Characteristics
ColorblueScoreno score
ShapeOVALSize12mm
FlavorImprint Code 144
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-9608-0550 in 1 BOTTLE; Type 0: Not a Combination Product06/30/2019
2NDC:0363-9608-20200 in 1 BOTTLE; Type 0: Not a Combination Product06/30/2019
3NDC:0363-9608-27270 in 1 BOTTLE; Type 0: Not a Combination Product06/30/2019
4NDC:0363-9608-61600 in 1 BOTTLE; Type 0: Not a Combination Product06/30/2019
5NDC:0363-9608-091 in 1 CARTON06/26/2021
590 in 1 BOTTLE; Type 0: Not a Combination Product
6NDC:0363-9608-9090 in 1 BOTTLE; Type 0: Not a Combination Product04/01/2022
7NDC:0363-9608-421 in 1 CARTON06/30/2019
724 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09054506/26/2019
Labeler - WALGREENS (008965063)
Registrant - TIME CAP LABORATORIES, INC (037052099)
Establishment
NameAddressID/FEIBusiness Operations
MARKSANS PHARMA LTD925822975manufacture(0363-9608)

Revised: 3/2024
Document Id: 13aeca7d-1120-844d-e063-6294a90ac3d9
Set id: 8771b84f-47bf-116c-e053-2995a90a0aad
Version: 9
Effective Time: 20240315
 
WALGREENS