Salsalate (Page 4 of 4)

HOW SUPPLIED

500mg Tablets: Supplied in bottles of

100ct (NDC 10135-0492-01)

500ct (NDC 10135-0492-05)

1000ct (NDC 10135-0492-10)

Appearance: Yellow colored, round, film-coated tablets debossed “AN” over “512” on one side and plain on the other.

750mg Tablets: Supplied in bottles of

100ct (NDC 10135-0493-01)

500ct (NDC 10135-0493-05)

1000ct (NDC 10135-0493-10)

Appearance: Yellow colored, capsule-shaped, scored, film-coated tablets debossed “AN 513” on one side and plain on the other.

Dispense contents with a child-resistant closure (as required) and in a tight container as defined in the USP.

Store at 20°C to 25°C (68-77°F): excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature].

Rx Only

REFERENCES

1. Morris HG, Sherman NA, McQuain C, et al: Effects of Salsalate (Non- Acetylated Salicylate) and Aspirin (ASA) on Serum Prostaglandins in Humans. Ther. Drug Monit. 7:435-438, 1985.
   
2. April PA, Curran NJ, Ekohlm BP, et al: Multicenter Comparative Study of Salsalate (SSA) vs Aspirin (ASA) in Rheumatoid Arthritis (RA), Arthritis Rheumatism 30 (4 supplement):S93, 1987.
   
3. Deodhar SD, McLeod MM, Dick WC, et al: A Short-Term Comparative Trial of Salsalate and Indomethacin in Rheumatoid Arthritis. Curr. Med. Res. Opin., 5:185-188,1977.
   
4. Estes D, Kaplan K: Lack of Platelet Effect With the Aspirin Analog, Salsalate, Arthritis and Rheumatism, 23:1303-1307, 1980.
   
5. Dick C, Dick PH, Nuki G, et al: Effect of Anti-inflammatory Drug Therapy on Clearance of 133Xe from Knee Joints of Patients with Rheumatoid Arthritis. British Med. J. 3:278-280, 1969.
   
6. Dick WC, Grayson MF, Woodburn A, et al: Indices of Inflammatory Activity. Ann. of the Rheum. Dis. 29:643-648, 1970.
   
7. Cohen A:Fecal Blood Loss and Plasma Salicylate Study of Salicylsalicylic Acid and Aspirin. J. Clin. Pharmacol. 19:242-247, 1979.
   
8. Chudwin DS, Strub M. Golden HE, et al: Sensitivity to Non-Acetylated Salicylates in a Patient with Asthma, Nasal Polyps, and Rheumatoid Arthritis. Annals of Allergy 57:133-134, 1986.
   
9. Spector SL, Wangaard CH, Farr RS: Aspirin and Concomitant Idiosyncrasies in Adult Asthmatic Patients. J. Allergy Clin. Immunol 64:500-506, 1979.
   
10. Stevenson DD, Schrank PJ, Hougham AJ, et al: Salsalate Cross Sensitivity in Aspirin-Sensitive Asthmatics. J. Allergy Clin. Immunol 81:181, 1988.

Manufactured by:
Amneal Pharmaceuticals
Paterson, NJ 07504

Distributed by:
Marlex Pharmaceuticals, Inc.
50 McCullough DriveNew Castle, DE 19720

Repackaging Information

Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma — TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

Count	750 mg
60	67544-410-53
90	67544-410-60
120	67544-410-70
180	67544-410-80
270	67544-410-92
360	67544-410-94

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:

Cookeville, TN 38506
20171220DKJ

PRINCIPAL DISPLAY PANEL — 750mg

NDC 67544-0410 Salsalate 750mg — Rx Only

SALSALATE salsalate tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67544-410(NDC:10135-493) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALSALATE (SALSALATE) SALSALATE 750 mg

Inactive Ingredients Ingredient Name Strength CARNAUBA WAX SILICON DIOXIDE CROSCARMELLOSE SODIUM D&C YELLOW NO. 10 HYPROMELLOSES CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL STEARIC ACID TITANIUM DIOXIDE

Product Characteristics Color YELLOW Score no score Shape CAPSULE Size 19mm Flavor Imprint Code AN;513 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:67544-410-53 60 TABLET, FILM COATED in 1 BOTTLE None 2 NDC:67544-410-60 90 TABLET, FILM COATED in 1 BOTTLE None 3 NDC:67544-410-70 120 TABLET, FILM COATED in 1 BOTTLE None 4 NDC:67544-410-80 180 TABLET, FILM COATED in 1 BOTTLE None 5 NDC:67544-410-92 270 TABLET, FILM COATED in 1 BOTTLE None 6 NDC:67544-410-94 360 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 04/01/2007

Labeler — Aphena Pharma Solutions — Tennessee, LLC (128385585)

Establishment
Name	Address	ID/FEI	Operations
Aphena Pharma Solutions — Tennessee, LLC		128385585	REPACK (67544-410)

Revised: 12/2017 Aphena Pharma Solutions — Tennessee, LLC