TREXIMET- sumatriptan and naproxen sodium tablet, film coated 
Glaxo Operations UK Ltd

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Principal Display Panel

NDC 0173-0750-49

Treximet®

(sumatriptan and naproxen sodium) Tablets

85 mg/500 mg

Rx only

Do not repackage; dispense and store in original container.

9 Tablets

Visit Treximet.com

Federal Law requires the dispensing of TREXIMET®Tablets with the attached Medication Guide.

Do not use if printed safety seal is broken or missing.

Each tablet contains 85 mg of sumatriptan and 500 mg of naproxen sodium.

See Prescribing Information for complete dosage information.

Do not split, crush, or chew tablets.

Store at 25°C (77°F); [see USP].

GlaxoSmithKline

RTP, NC 27709

Made in UK

Rev. 6/12

©2012 GlaxoSmithKline

10000000105242

Treximet 9 count label
TREXIMET 
sumatriptan and naproxen sodium tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63379-039
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SUMATRIPTAN SUCCINATE (UNII: J8BDZ68989) (SUMATRIPTAN - UNII:8R78F6L9VO) SUMATRIPTAN85 mg
NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN SODIUM500 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
DEXTROSE MONOHYDRATE (UNII: LX22YL083G)  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorBLUEScoreno score
ShapeCAPSULE (capsule-shaped) Size19mm
FlavorImprint Code TREXIMET
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63379-039-029 in 1 CONTAINER; Type 0: Not a Combination Product04/25/2008
2NDC:63379-039-019 in 1 BOTTLE; Type 0: Not a Combination Product04/25/2008
3NDC:63379-039-001 in 1 BOTTLE; Type 0: Not a Combination Product04/25/2008
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Approved Drug Product Manufactured Under ContractNDA02192604/25/2008
Labeler - Glaxo Operations UK Ltd (424738227)

Revised: 12/2017
Document Id: 8ee6fc5a-00e9-4bc7-b688-64c1be7cbc4f
Set id: d2329b4d-1359-4d8c-b58d-d7e7ceceb3bb
Version: 3
Effective Time: 20171206
 
Glaxo Operations UK Ltd