Salsalate (Page 4 of 4)

HOW SUPPLIED

Salsalate Tablets, USP, 500 mg are circular, blue colored film coated tablet, scored, debossed “103/103″ on one side, and “Caraco Logo” debossed on other side.

Bottles of 100 NDC 57664-103-08

Bottles of 500 NDC 57664-103-13

Bottles of 1000 NDC 57664-103-18

Salsalate Tablets, USP, 750 mg are capsule shaped, blue colored film coated tablet, debossed “105″ on one side, and “C/C” scored on other side.

Bottles of 100 NDC 57664-105-08

Bottles of 500 NDC 57664-105-13

Bottles of 1000 NDC 57664-105-18

Store at controlled room temperature 15-30°C (59-86°F).

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.

Distributed by: C.S. No. 5015T33
Caraco Pharmaceutical Laboratories, Ltd. Iss 03/08
1150 Elijah McCoy Drive,
Detroit, MI 48202

Salsalate 750 MG Tablet

Label
(click image for full-size original)
SALSALATE
salsalate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63629-3783(NDC:57664-105)
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
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A POTATO
POVIDONES
STEARIC ACID
HYPROMELLOSES
POLYDEXTROSE
TITANIUM DIOXIDE
TRIACETIN
FD&C BLUE NO. 1
FD&C BLUE NO. 2
POLYETHYLENE GLYCOLS
Product Characteristics
Color BLUE Score 2 pieces
Shape CAPSULE Size 19mm
Flavor Imprint Code 105;C
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63629-3783-1 60 TABLET in 1 BOTTLE None
2 NDC:63629-3783-2 28 TABLET in 1 BOTTLE None
3 NDC:63629-3783-3 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 04/01/1995
Labeler — Bryant Ranch Prepack (171714327)
Registrant — Bryant Ranch Prepack (171714327)
Establishment
Name Address ID/FEI Operations
Bryant Ranch Prepack 171714327 REPACK (63629-3783), RELABEL (63629-3783)

Revised: 05/2013 Bryant Ranch Prepack

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