NAPROXEN SODIUM- naproxen sodium tablet, film coated 
TIME CAP LABORATORIES, INC

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609R 49483-609 Naproxen Sodium Tablets 220 mg

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
temporarily relieves minor aches and pains due to:

temporarily reduces fever

Warnings
Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

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:

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

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
you experience any of the following signs of stomach bleeding:

you have symptoms of heart problems or stroke:

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 (1-800-222-1222)

Directions

adults and children 12 years and older:

children under 12 years:

OTHER INFORMATION

Other information

Inactive ingredients 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

609R-TCL-Naproxen-bottle-label-100s609R-TCL-Naproxen-bottle-label-50s

NAPROXEN SODIUM 
naproxen sodium tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49483-609
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN220 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorblueScoreno score
ShapeROUNDSize10mm
FlavorImprint Code 141
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49483-609-006500 in 1 BAG; Type 0: Not a Combination Product03/28/2016
2NDC:49483-609-0550 in 1 BOTTLE; Type 0: Not a Combination Product03/28/2016
3NDC:49483-609-01100 in 1 BOTTLE; Type 0: Not a Combination Product03/28/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09054503/28/2016
Labeler - TIME CAP LABORATORIES, INC (037052099)
Registrant - TIME CAP LABORATORIES, INC (037052099)
Establishment
NameAddressID/FEIBusiness Operations
MARKSANS PHARMA LIMITED925822975manufacture(49483-609)

Revised: 12/2021
Document Id: cbf198fe-25e4-694c-e053-2995a90aae22
Set id: 17ecaee0-c1c6-4360-81c1-d6afe50b9b27
Version: 4
Effective Time: 20211201
 
TIME CAP LABORATORIES, INC