SALSALATE (Page 4 of 4)

Repackaging Information

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

Count 750mg
60 43353-771-53
120 43353-771-70
180 43353-771-80
270 43353-771-92
360 43353-771-94

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.

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:
Cispharma Inc.
1212 Cranbury S River Road
Cranbury, NJ 08512

Distributed by:
Libertas Pharma, Inc.
Lawrenceville, GA 30043

Repackaged by:
Aphena Pharma Solutions -- TN
Cookeville, TN 38506
20120814AW

PRINCIPAL DISPLAY PANEL

NDC 43353-771
Salsalate 750mg
Rx Only

Bottle Label 750mg
(click image for full-size original)

SALSALATE
salsalate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43353-771(NDC:51862-142)
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
COLLOIDAL SILICON DIOXIDE
CROSCARMELLOSE SODIUM
D&C YELLOW NO. 10
HYPROMELLOSES
MICROCRYSTALLINE WAX
MINERAL OIL
POLYETHYLENE GLYCOL
STEARIC ACID
TALC
TITANIUM DIOXIDE
Product Characteristics
Color YELLOW (YELLOW) Score no score
Shape CAPSULE (Capsule) Size 17mm
Flavor Imprint Code SL;750
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43353-771-53 60 TABLET (60 TABLET) in 1 BOTTLE, PLASTIC None
2 NDC:43353-771-70 120 TABLET (120 TABLET) in 1 BOTTLE, PLASTIC None
3 NDC:43353-771-80 180 TABLET (180 TABLET) in 1 BOTTLE, PLASTIC None
4 NDC:43353-771-92 270 TABLET (270 TABLET) in 1 BOTTLE, PLASTIC None
5 NDC:43353-771-94 360 TABLET (360 TABLET) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 05/22/2011
Labeler — Aphena Pharma Solutions — Tennessee, Inc. (128385585)
Establishment
Name Address ID/FEI Operations
Aphena Pharma Solutions — Tennessee, Inc. 128385585 Repack (43353-771)

Revised: 03/2012 Aphena Pharma Solutions — Tennessee, Inc.

Page 4 of 4 1 2 3 4

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2020. All Rights Reserved.