Adult Dosing
Moderate to moderately severe pain
- 2 caps [641 mg/60 mg/32 mg] PO q4 hrs PRN; alt: 1 tab (712.8 mg/60 mg/32 mg) PO q4 hrs PRN
- Max: [2 caps or 1 tab]/4 hrs; [10 caps or 5 tabs]/day
Pediatric Dosing
- Safety and effectiveness in pediatric patients have not been established
[Outline]
See Supplemental Patient Information
- Overdosage of this product may cause severe liver damage, which may occur on exceeding recommended dosages, concomitant use with other drugs containing acetaminophen, or on consuming 3 or more alcoholic drinks every day while receiving therapy. Avoid concomitant use with any other drugs containing acetaminophen
- There are post-marketing reports of hypersensitivity and anaphylaxis associated with acetaminophen component of this combination drug. Instruct patients to discontinue therapy immediately and seek medical help if symptoms such as swelling of the face, mouth and throat, respiratory distress, urticaria, rash, pruritus, and vomiting occur
- Dihydrocodeine may impair mental and/or physical abilities essential for performing potentially hazardous tasks such as driving a car or operating machinery
- Therapy may cause respiratory depression, although rarely severe with usual doses. Dihydrocodeine component of this combination drug decreases the respiratory rate, tidal volume, minute ventilation, and sensitivity to carbon dioxide
- Respiratory depression mostly occurs in elderly or debilitated patients after large initial doses in nontolerant patients, or when opioids are given in combination with other agents that depress respiration
- Consider alternative non-opioid analgesics or administer opioids only under careful medical supervision at the lowest effective dose in patients with significant COPD or corpulmonale and in patients with a substantially decreased respiratory reserve, hypoxia, hypercapnia, or respiratory depression
- Therapy may obscure neurologic signs of increases in intracranial pressure in patients with head injuries. The respiratory depressant effects such as carbon dioxide retention and secondary elevation of cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, intracranial lesions, or other causes of increased ICP
- Therapy may cause hypotension in patients whose ability to maintain blood pressure has been compromised by a depleted blood volume or who receive concomitant therapy with drugs such as phenothiazines or other agents which compromise vasomotor tone
- Product may produce orthostatic hypotension in ambulatory patients; use cautiously in patients who are in circulatory shock as vasodilation produced by the drug may further decrease cardiac output and blood pressure
- Therapy may produce drug dependence of the codeine type
- Carefully consider the risks and benefits of opioid therapy in patients with a history of drug abuse and in those taking monoamine oxidase inhibitors
- Therapy may obscure the diagnosis or clinical course in patients with acute abdominal conditions
- Product may aggravate convulsions in patients with convulsive disorders and may induce or aggravate seizures
- Caffeine in high doses may produce CNS and CV stimulation and GI irritation
Cautions: Use cautiously in
- Hepatic impairment
- Renal impairment
- Pulmonary impairment
- Head injury
- Elevated ICP
- Seizure disorder
- Elderly patients
- Debilitated patients
- Addison's disease
- Acute alcoholism
- History of drug abuse
- G6PD deficiency
- Acute abdomen
- Severe inflammatory bowel disease
- Pseudomembranous colitis
- Gallbladder disease
- Asthma
- CNS depression or coma
- Delirium tremens
- Hypotension
- Myxedema or hypothyroidism
- Prostatic hypertrophy
- Urethral stricture
- Toxic psychosis
- Smoking habit changes
Supplemental Patient Information
- Advise patients to avoid driving a motor vehicle or operating machinery, as therapy may impair the mental or physical abilities required for performing such tasks
- Instruct patients to avoid alcoholic beverages during therapy
Pregnancy Category:C
Breastfeeding: Acetaminophen is a good choice for analgesia and fever reduction in nursing mothers. Amounts excreted in milk are much less than doses usually given to infants. Adverse effects in breastfed infants appear to be rare. Caffeine appears in breastmilk rapidly after maternal ingestion. Adverse events like fussiness, jitteriness, and poor sleep patterns have been reported in the infants of mothers with very high caffeine intakes equivalent to 10 or more cups of coffee daily. No stimulatory effects on infants 
3 wks were observed in mothers taking 5 cups of coffee daily. Preterm and younger newborn infants metabolize caffeine very slowly and may have serum levels of caffeine and other active caffeine metabolites similar to their mothers'. Decreased breastmilk iron concentrations causing mild iron deficiency anemia in some breastfed infants may occur on intake of >450 mL of coffee. This information is based upon Lactmed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 31 August 2011). As per manufacturer's data, acetaminophen, caffeine, and dihydrocodeine are excreted in small amounts in breast milk. Due to the potential for serious adverse reactions in nursing infants from this combination drug, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
US Trade Name(s)
US Availability
acetaminophen/caffeine/dihydrocodeine (generic)
- OTC CAPS: 356.4 mg/30 mg/16 mg
- OTC TABS: 712.8 mg/60 mg/32 mg
Trezix (acetaminophen/caffeine/dihydrocodeine)
- OTC CAPS: 320.5 mg/30 mg/16 mg
Canadian Trade Name(s)
Canadian Availability
UK Trade Name(s)
UK Availability
Australian Trade Name(s)
Australian Availability
[Outline]
Drug Name: Acetaminophen 712.8 MG / caffeine 60 MG / dihydrocodeine 32 MG Oral Tablet
Ingredient(s): Acetaminophen mixture with Caffeine and dihydrocodeine
Imprint: Boca;611
Color(s): White
Shape: Oval
Size (mm): 19.00
Score: 2
Inactive Ingredient(s): crospovidone / magnesium stearate / cellulose, microcrystalline / povidone / starch, corn / stearic acid
Drug Label Author:
Boca Pharmacal, Inc.
DEA Schedule:
CIII
Drug Name: Acetaminophen 712.8 MG / caffeine 60 MG / dihydrocodeine 32 MG Oral Tablet
Ingredient(s): Acetaminophen mixture with Caffeine and dihydrocodeine
Imprint: PAL;032
Color(s): Purple
Shape: Oval
Size (mm): 19.00
Score: 2
Inactive Ingredient(s): colloidal silicon dioxide / crospovidone / d & c red # 30 aluminum lake / d & c red #27 aluminum lake / fd & c blue # 1 aluminum lake / magnesium stearate (powder) / microcrystalline cellulose / povidone / pregelatinized starch / stearic acid
Drug Label Author:
MIKART, INC.
DEA Schedule:
CIII