Salsalate (Page 4 of 4)

Children

Dosage recommendations and indications for salsalate use in children have not been established.

HOW SUPPLIED

500 mg Tablets in bottles of 100 ct (NDC 69367-160-04)
500 mg Tablets in bottles of 500 ct (NDC 69367-160-06)
Appearance, 500 mg: Yellow Colored, round, film-coated tablets debossed ‘809’ on one side and plain on the other.

750 mg Tablets in bottles of 100 ct (NDC 69367-161-04)
750 mg Tablets in bottles of 500 ct (NDC 69367-161-06)
Appearance, 750 mg: Yellow colored, capsule-shaped, film-coated tablets debossed ‘810’ on one side and bisect 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°F to 77°F); excursions permitted to 15° to 30°C (59° to 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. Opi; 5:185-188, 1977.
  4. Estes D, Kaplan K: Lack of Platelet Effect With the Aspirin Analog, Salsalate, Arthritis and Rheumatism, 3:1303-1307, 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, 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 57:133134, 1986.
  9. Spector SL, Wangaard CH, Farr RS: Aspirin and Concomitant Idiosyncrasies in Adult Asthmatic Patients. J. llergy 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:
Westminster Pharmaceuticals, LLC
Nashville, TN 37217
Rev. 04/20

PRINCIPAL DISPLAY PANEL — 500 mg Tablet Bottle Label

NDC 69367-160-04

Rx Only

Salsalate
Tablets, USP

500 mg

100 Tablets

Westminster
Pharmaceuticals

PRINCIPAL DISPLAY PANEL -- 500 mg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 750 mg Tablet Bottle Label

NDC 69367-161-04

Rx Only

Salsalate
Tablets, USP

750 mg

100 Tablets

Westminster
Pharmaceuticals

PRINCIPAL DISPLAY PANEL -- 750 mg Tablet Bottle Label
(click image for full-size original)
SALSALATE
salsalate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69367-160
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Salsalate (Salsalate) Salsalate 500 mg
Product Characteristics
Color YELLOW Score no score
Shape ROUND Size 11mm
Flavor Imprint Code 809
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69367-160-04 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 08/24/2017
SALSALATE
salsalate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69367-161
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Salsalate (Salsalate) Salsalate 750 mg
Product Characteristics
Color YELLOW Score 2 pieces
Shape OVAL Size 80mm
Flavor Imprint Code 810
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69367-161-04 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 08/24/2017
Labeler — Westminster Pharmaceuticals, LLC (079516651)

Revised: 06/2020 Westminster Pharmaceuticals, LLC

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