ge, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
ADVERSE REACTIONS
The most frequently observed reactions include lightheadedness, dizziness, drowsiness, sedation, nausea, vomiting, constipation, pruritus, and skin reactions.
DOSAGE AND ADMINISTRATION
Dosage should be adjusted according to the severity of the pain and the response of the patient. Synalgos-DC is given orally. The usual adult dose is two capsules every 4 hours as needed for pain.
HOW SUPPLIED
Synalgos®-DC Capsules are blue and gray, marked “CP” and “419”, supplied in:
Bottles of 100 capsules; NDC 49708-419-88
Store at room temperature, approx. 25°C (77°F). Keep tightly closed.
Dispense in tight container.
Manufactured by:C.S. No.:8002T01
Mikart, Inc.Rev. 10/09
Atlanta, Georgia 30318Code 990B00
Distributed by:
Caraco Pharmaceutical Laboratories, Ltd.
1150 Elijah McCoy Drive
Detroit, MI 48202
www.caraco.com
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 49708-419-88
100 Capsules
Synalgos®-DC
(dihydrocodeine bitartrate, aspirin, and caffeine capsules)
Each capsule contains: 16 mg drocode (dihydrocodeine) bitartrate (Warning–may
be habit-forming), 356.4 mg aspirin, and 30 mg caffeine.
SEALED FOR YOUR PROTECTION
Rx Only
Caraco Pharma, Inc.
SYNALGOS
dihydrocodeine bitartrate, aspirin and caffeine capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 49708-419
Route of Administration ORAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIHYDROCODEINE BITARTRATE(DIHYDROCODEINE) DIHYDROCODEINE BITARTRATE 16mg
ASPIRIN(ASPIRIN) ASPIRIN 356.4mg
CAFFEINE(CAFFEINE) CAFFEINE 30mg
Inactive Ingredients
Ingredient Name Strength
ALGINIC ACID
POWDERED CELLULOSE
D&C RED NO. 28
FD&C BLUE NO. 1
GELATIN
FERROSOFERRIC OXIDE
STEARIC ACID
TITANIUM DIOXIDE
Product Characteristics
Color BLUE,GRAY Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code CP;419
Contains
Packaging
# NDC Package Description Multilevel Packaging
1 49708-419-88 100CAPSULEIn1BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA011483 12/30/2008
Labeler -Caraco Pharma Inc.(831527945)
Registrant -Mikart, Inc. (030034847)
Establishment
Name Address ID/FEI Operations
