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 for and Distributed by:

Marlex Pharmaceuticals, Inc.

New Castle, DE 19720

PRINCIPAL DISPLAY PANEL

MARLEX PHARMACEUTICALS, INC.
NDC 10135-492-10
Salsalate
Tablets, USP
500 mg
Rx ONLY 1000 TABLETS

MARLEX PHARMACEUTICALS, INC.
NDC 10135-492-10
Salsalate 
Tablets, USP 
500 mg 
Rx ONLY 
1000 TABLETS
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

MARLEX PHARMACEUTICALS, INC.
NDC 10135-493-10
Salsalate
Tablets, USP
750 mg
Rx ONLY
1000 CAPLETS** (Capsule-Shaped Tablets)

MARLEX PHARMACEUTICALS, INC.
NDC 10135-493-10
Salsalate 
Tablets, USP 
750 mg 
Rx ONLY 
1000 CAPLETS*
* (Capsule-Shaped Tablets)
(click image for full-size original)
SALSALATE salsalate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10135-492
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALSALATE (SALSALATE) SALSALATE 500 mg
Inactive Ingredients
Ingredient Name Strength
CARNAUBA WAX
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
D&C YELLOW NO. 10
HYPROMELLOSES
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL, UNSPECIFIED
STEARIC ACID
TITANIUM DIOXIDE
Product Characteristics
Color YELLOW Score no score
Shape ROUND Size 11mm
Flavor Imprint Code AN;512
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10135-492-01 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:10135-492-05 500 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:10135-492-10 1000 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
SALSALATE salsalate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) 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, UNSPECIFIED
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:10135-493-01 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:10135-493-05 500 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:10135-493-10 1000 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 — Marlex Pharmaceuticals Inc (782540215)

Revised: 12/2019 Marlex Pharmaceuticals Inc

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