spirin, and caffeine capsule did not include sufficient numbers of subjects aged 65 and over to determine whether elderly subjects respond differently from younger subjects.
In general, dose selection for an elderly patient should be cautious, starting at the low end of the dosing range, 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. The dihydrocodeine bitartrate, aspirin, and caffeine capsule is given orally. The usual adult dose is two capsules every 4 hours as needed for pain.
HOW SUPPLIED
Dihydrocodeine bitartrate, aspirin, and caffeine Capsules are blue and gray, marked “CP” and “419”, supplied in:
Bottles of 100 capsules; NDC 57902-419-88
Store at room temperature, approx. 25°C (77°F). Keep tightly closed.
Dispense in tight container.
Manufactured for and distributed by:
EUSA Pharma (USA), Inc.
One Summit Square, Suite 201
1717 Langhorne Newtown Rd.
Langhorne, PA 19047
www.eusapharma.com
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 57902-419-88
100 Capsules
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
EUSAPharma (USA), Inc.
DIHYDROCODEINE BITARTRATE AND ASPIRIN AND CAFFEINEDC
dihydrocodeine bitartrate and aspirin and caffeine capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 57902-419(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 57902-419-88 100CAPSULEIn1BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA011483 04/25/2011
Labeler -EUSA Pharma (USA), Inc.(038596862)
