CHOLINE MAGNESIUM TRISALICYLATE: Package Insert and Label Information (Page 2 of 2)

HOW SUPPLIED

Choline Magnesium Trisalicylate Liquid is supplied in bottles of 240 mL.

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

REFERENCES:
1. Szczeklik, A et al; Choline magnesium trisalicylate in patients with aspirin-induced asthma; Eur. Respir. J; 3:535-539, 1990.
2. Zucker, MB and Rothwell, KB; Differential influences of salicylate compounds on platelet aggregation and serotonin release; Current Therapeutic Research; 23(2), Feb 1987.
3. Stuart, JJ and Pisko, EJ; Choline magnesium trisalicylate does not impair platelet aggregation; Pharmatherapeutica; 2(8):547, 1981.
4. Danesh, BJZ, Saniabadi, AR, Russell, RI et al; Therapeutic potential of choline magnesium trisalicylate as an alternative to aspirin for patients with bleeding tendencies;
Scottish Medical Journal; 32:167-168, 1987.
5. Danesh, BJZ, McLaren, M, Russell, RI et al; Does non-acetylated salicylate inhibit thromboxane biosynthesis in human platelets? Scottish Medical Journal; 33:315-316,
1988.
6. Danesh, BJZ, McLaren, M, Russell, RI et al; Comparison of the effect of aspirin and choline magnesium trisalicylate on thromboxane biosynthesis in human platelets: role of
the acetyl moiety; Haemostasis; 19:169-173, 1989.
7. Data on file. Medical Department. The Purdue Frederick Company, 1989.
8. Blechman, WJ and Lechner, BL; Clinical comparative evaluation of choline magnesium trisalicylate and acetylsalicylic acid in rheumatoid arthritis; Rheumatology and
Rehabilitation; 18:119-124, 1979.
9. McLaughlin, G; Choline magnesium trisalicylate vs. naproxen in rheumatoid arthritis; Current Therapeutic Research; 32(4):579-585, 1982.
10. Ehrlich, GE, Miller, SB, and Zeiders, RS; Choline magnesium trisalicylate vs. ibuprofen in rheumatoid arthritis; Rheumatology and Rehabilitation; 19:30-41, 1980.
11. Goldenberg, A, Rudnicki, RD, and Koonce, ML; Clinical comparison of efficacy and safety of choline magnesium trisalicylate and indomethacin in treating osteoarthritis;
Current Therapeutic Research; 24(3):245-260, 1978.
12. Guerin, BK and Burnstein, SL; Conservative therapy of acute painful shoulder; Orthopedic Review; XI (7):29-37, 1982.

Manufactured by:
Silarx Pharmaceutical, Inc.Carmel, NY 10512 USA

Container Label
(click image for full-size original)
CHOLINE MAGNESIUM TRISALICYLATE choline magnesium trisalicylate liquid
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54838-522
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHOLINE MAGNESIUM TRISALICYLATE (SALICYLIC ACID) SALICYLIC ACID 500 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
CARBOXYMETHYLCELLULOSE SODIUM
EDETATE DISODIUM
FD&C YELLOW NO. 6
GLYCERIN
METHYLPARABEN
POTASSIUM SORBATE
SODIUM CITRATE
SORBIC ACID
SORBITOL
WATER
Product Characteristics
Color BROWN (caramel color) Score
Shape Size
Flavor CHERRY (black cherry flavor) Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54838-522-70 240 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 02/05/1997
Labeler — Lannett Company, Inc. (161630033)

Revised: 06/2014 Lannett Company, Inc.

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