Codeine Phosphate

Pronunciation

Class: Opiate Agonists
Note: This monograph also contains information on Codeine, Codeine Sulfate
VA Class: CN101
Chemical Name: (5α,6α)-7,8-Didehydro-4,5-epoxy-3-methoxy-17-methyl-morphan-6-ol phosphate
Molecular Formula: C18H21NO3•H3PO4•½H2O
CAS Number: 41444-62-6
Brands: Ala-Hist AC (combination), Ascomp with Codeine (combination), Capital and Codeine, Cheratussin AC (combination), Cheratussin DAC (combination), Codar AR (combination), Codar D (combination), Codar GF (combination), EndaCof- C (combination), Fioricet with Codeine, Fiorinal with Codeine, Guaiatussin AC, Lortuss EX (combination), Neo AC (combination), Poly-tussin, Poly-tussin AC (combination), Poly-tussin D (combination), Pro-Clear AC (combination), Pro-Red AC (combination), Robafen AC, Rydex (combination), Soma Compound with Codeine, Statuss Green (combination), Triacin-C, Tricode AR (combination), Tricode GF (combination), Tylenol with Codeine, Z-Tuss AC (combination), Z-Tuss E (combination)

Warning(s)

Special Alerts:

[UPDATED 02/20/2013] FDA notified the public about new actions being taken to address a known safety concern with codeine use in certain children after tonsillectomy and/or adenoidectomy (surgery to remove the tonsils and/or adenoids). A new BOXED WARNING, FDA’s strongest warning, will be added to the drug label of codeine-containing products about the risk of codeine in post-operative pain management in children following tonsillectomy and/or adenoidectomy. A Contraindication, which is a formal means for FDA to make a strong recommendation against use of a drug in certain patients, will be added to restrict codeine from being used in this setting. The Warnings/Precautions, Pediatric Use, and Patient Counseling Information sections of the drug label will also be updated.

Health care professionals should prescribe an alternate analgesic for post-operative pain control in children who are undergoing tonsillectomy and/or adenoidectomy. Codeine should not be used for pain in children following these procedures.

For management of other types of pain in children, codeine should only be used if the benefits are anticipated to outweigh the risks.

[Posted 08/15/2012] ISSUE: The FDA is reviewing reports of children who developed serious adverse effects or died after taking codeine for pain relief after tonsillectomy and/or adenoidectomy for obstructive sleep apnea syndrome. Recently, three pediatric deaths and one non-fatal but life-threatening case of respiratory depression were documented in the medical literature.

These children (ages two to five) had evidence of an inherited (genetic) ability to convert codeine into life-threatening or fatal amounts of morphine in the body. All children had received doses of codeine that were within the typical dose range.

BACKGROUND: When codeine is ingested, it is converted to morphine in the liver by an enzyme called cytochrome P450 2D6 (CYP2D6). Some people have DNA variations that make this enzyme more active, causing codeine to be converted to morphine faster and more completely than in other people. These “ultra-rapid metabolizers” are more likely to have higher than normal amounts of morphine in their blood after taking codeine. High levels of morphine can result in breathing difficulty, which may be fatal. Taking codeine after tonsillectomy and/or adenoidectomy may increase the risk for breathing problems and death in children who are “ultra-rapid metabolizers.” See the FDA Drug Safety Communication for additional information, including a Data Summary.

RECOMMENDATION: Health care professionals should be aware of the risks of using codeine in children, particularly in those who have undergone tonsillectomy and/or adenoidectomy for obstructive sleep apnea syndrome. If prescribing codeine-containing drugs, the lowest effective dose for the shortest period of time should be used on an as-needed basis (i.e., not scheduled around the clock).

Parents and caregivers who observe unusual sleepiness, confusion, or difficult or noisy breathing in their child should seek medical attention immediately, as these are signs of overdose. For more information visit the FDA website at: and .

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Introduction

Opiate agonist; phenanthrene derivative.a b

Uses for Codeine Phosphate

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Pain

Symptomatic relief of mild to moderate pain that is not relieved by a non-opiate analgesic.b d e f

Slideshow: Prescription Drug Addiction - Top 18 Facts for You and Your Family

Combinations of codeine and aspirin or acetaminophen may produce additive analgesic effects because of differing mechanisms of action.b

Cough

Symptomatic relief of nonproductive cough, alone or in combination with other antitussives or expectorants.a

Codeine Phosphate Dosage and Administration

Administration

Oral Administration

Administer orally.a b

Dispense a calibrated measuring device with cough preparations intended for children 2–5 years of age.103

Dosage

Available as codeine phosphate and codeine sulfate; dosage expressed in terms of the salt.d e g

Pediatric Patients

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Cough
Oral
Usual Pediatric Antitussive Dosages

Age

Daily Dosage

2–5 years

1 mg/kg daily in 4 equally divided doses every 4–6 hours100 101 103

6–11 years

5–10 mg every 4–6 hours100 101 103

≥12 years

10–20 mg every 4–6 hoursa

Alternatively, use the following dosages as a guide based on average body weight; reduce dosage for low-weight children.100

Antitussive Dosages for Pediatric Patients Based on Weight100

Age

Daily Dosage

2 years (averaging 12 kg)

3 mg every 4–6 hours (maximum 12 mg daily)

3 years (averaging 14 kg)

3.5 mg every 4–6 hours (maximum 14 mg daily)

4 years (averaging 16 kg)

4 mg every 4–6 hours (maximum 16 mg daily)

5 years (averaging 18 kg)

4.5 mg every 4–6 hours (maximum 18 mg daily)

Pain
Oral

3 mg/kg or 100 mg/m2 daily in 6 divided doses.b Alternatively, 0.5 mg/kg or 15 mg/m2 every 4–6 hours.b f

Adults

Cough
Oral

10–20 mg every 4–6 hours.a

Pain
Oral

30 mg every 4 hours as needed; usual dosage range is 15–60 mg every 4 hours as needed.b d e

Nonopiate-containing analgesic fixed combinations: Nonopiate component may limit dosage of opiate component.117 119 120 121 Nonopiate analgesics are available in various fixed ratios with codeine and also are available in many other prescription and OTC preparations; ensure that therapy is not duplicated and that nonopiate dosage does not exceed maximum recommended dosages.117 118 119 121

Prescribing Limits

Pediatric Patients

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Cough
Oral
Maximum Daily Antitussive Dosages for Pediatric Patients

Age

Maximum Daily Dosage

2 years (averaging 12 kg)

12 mg100

3 years (averaging 14 kg)

14 mg 100

4 years (averaging 16 kg)

16 mg 100

5 years (averaging 18 kg)

18 mg 100

6–11 years

60 mg a

≥12 years

120 mg a

Adults

Cough
Oral

Maximum 120 mg daily.a

Special Populations

Geriatric Patients

Reduce dosage in older patients.a b

Ultra-rapid Metabolizers of CYP2D6 Substrates

Use lowest effective dosage for shortest period of time.104 105 106 113 (See Special Populations under Pharmacokinetics.)

Cautions for Codeine Phosphate

Contraindications

  • Known hypersensitivity to codeine or any ingredient in the formulation.c d e f

Warnings/Precautions

Warnings

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

CNS Depression

Performance of activities requiring mental alertness and physical coordination may be impaired.a c d e f

Concurrent use of other CNS depressants may potentiate CNS depression.d e (See Specific Drugs under Interactions.)

Abuse Potential

Possible tolerance, psychologic dependence, and physical dependence following prolonged administration.a Abuse potential similar to that of morphine.d e f

Sulfite Sensitivity

Some formulations contain sulfites, which may cause allergic-type reactions (including anaphylaxis and life-threatening or less severe asthmatic episodes) in certain susceptible individuals.f

General Precautions

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Increased Intracranial Pressure or Head Trauma

Potential for increased respiratory depressant effects and elevation of CSF pressure in patients with increased intracranial pressure, head trauma, or other intracranial lesions.c d e f

Adverse effects of opiates may obscure the existence, extent, or course of intracranial pathology.d e f g

Acute Abdominal Conditions

Administration may complicate assessment of patients with acute abdominal conditions.c d e f

Respiratory Depression

Possible dose-related respiratory depressionc d e (occurs infrequently with oral antitussive doses).a

Potential for increased viscosity of bronchial secretions and suppression of cough reflex, with subsequent respiratory insufficiency, in patients with asthma or pulmonary emphysema who indiscriminately use antitussives.a

Postoperative Patients

Suppression of cough reflex following thoracotomy or laparotomy may lead to postoperative retention of secretions; cautious use recommended.a

Debilitated and Special Risk Patients

Use with caution in debilitated patients and in those with hypothyroidism, Addison’s disease, and prostatic hypertrophy or urethral stricture.a d e f

Fixed-combination Preparations

When used in fixed combination with other drug(s), consider the cautions, precautions, and contraindications associated with the other drug(s).b

Specific Populations

Pregnancy

Category C.f

Lactation

Distributed into milk. a Use with caution in nursing women who are known or suspected ultra-rapid metabolizers of CYP2D6 substrates; opioid toxicity resulting in neonatal death reported in the nursing infant of mother receiving codeine; mother was an ultra-rapid metabolizer of codeine.104 105 106 107 113 (See Metabolism and see Special Populations under Pharmacokinetics.)

The FDA-approved AmpliChip CYP450 Test can be used to identify CYP2D6 genotype.106 111 113 Testing alone may not adequately predict risk of adverse reactions and should not substitute for clinical judgment.104 If codeine is used in nursing women, administer lowest effective dosage for shortest possible time; closely monitor for opioid toxicity in both mother and infant.104 105 106 113

Pediatric Use

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Safety for the management of mild to moderate pain not established in children <3 years of age.d e f

Use as antitussive not recommended in children <2 years of age; possible respiratory arrest, coma, and death due to increased susceptibility to respiratory depressant effects.a

Risk of overdosage and toxicity (including death) in children <2 years of age receiving OTC preparations containing antihistamines, cough suppressants, expectorants, and nasal decongestants alone or in combination for relief of symptoms of upper respiratory tract infection.115 116 Clinicians should ask caregivers about use of OTC cough/cold preparations to avoid overdosage.

Geriatric Use

Use with caution.d e f g (See Geriatric Patients under Dosage and Administration.)

Hepatic Impairment

Use with caution in patients with severe hepatic impairment.d e f g

Renal Impairment

Use with caution in patients with severe renal impairment.d e f

Common Adverse Effects

When used for pain relief (particularly in ambulatory patients not experiencing severe pain): lightheadedness, dizziness, sedation, nausea, vomiting, sweating.d e f

When used at antitussive doses: nausea, vomiting, constipation (with repeated doses), dizziness, sedation, palpitation, pruritus.a

Interactions for Codeine Phosphate

Specific Drugs

Drug

Interaction

Comments

Anticholinergic agents

Possible paralytic ileusf

Antidepressants, MAO inhibitors and tricyclics

Potentiation of antidepressant effectc

Use with caution; reduce dosage of codeinec

CNS depressants (e.g., opiate agonists, general anesthetics, tranquilizers, phenothiazines, sedatives/hypnotics, alcohol)

Additive CNS effectsa d e f

Reduce dosage of one or both agentsd e f

Codeine Phosphate Pharmacokinetics

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Absorption

Bioavailability

Well absorbed following oral administration.a b e f g

Onset

Onset occurs in 15–30 minutes.a b Peak analgesic effects occur within 2 hours;g peak antitussive effects within 1–4 hours.i

Duration

Analgesic effects persist for 4–6 hours.b g Antitussive effects may persist for 4 hours.i

Distribution

Extent

Rapidly distributed into various body tissues, with preferential uptake by parenchymatous organs such as the liver, spleen, and kidney.g Distributed into milk.b Readily crosses the placenta.c

Protein Binding

Not bound to plasma proteins.g

Elimination

Metabolism

Metabolized in liver, principally by CYP3A4 and to a lesser extent (10%) by CYP2D6 to O-demethylated morphine, the active metabolite.b 108 109 110 112

Metabolism of codeine influenced by CYP2D6 polymorphism; genetic differences in drug metabolism affect drug response.108 109 110 112 114 Individuals may be described as poor, extensive, or ultra-rapid metabolizers of CYP2D6 substrates.108 109 110 112 114

Elimination Route

Excreted mainly in urine with negligible amounts of codeine and its metabolites found in feces.b g

Half-life

About 2.5–3 hours.f g

Special Populations

Individuals who carry the genotype associated with ultra-rapid metabolism of CYP2D6 substrates (approximately 1–7% of Caucasians, 10–30% of Ethiopians and Saudi Arabians) convert codeine to morphine more rapidly and completely than other individuals; ultra-rapid metabolizers are likely to have higher than expected serum concentrations of morphine.107 108 110 112 114

Stability

Storage

Oral

Tablets

Tight, light-resistant containers at <40°C (preferably 15–30°C).b

Solution

Tight, light-resistant containers at <40°C (preferably 15–30°C).h Protect from freezing.h

Actions

  • Principal pharmacologic effects are on CNS and intestines.c d e

  • Mild analgesic effect.b d e f Acts at several sites within the CNS involving several systems of neurotransmitters to produce analgesia; precise mechanism of action not fully elucidated.c

  • Suppresses cough reflex by direct effect on cough center in medulla of brain.a

  • Exerts drying effect on respiratory tract mucosa and increases viscosity of bronchial secretions.a

  • Antitussive activity is less than that of morphine (on a weight basis).a

Advice to Patients

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

  • Potential for drug to impair mental alertness or physical coordination; use caution when driving or operating machinery until effects on individual are known.d e f

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as alcohol consumption and any concomitant diseases.d e f Importance of limiting alcohol intake.f

  • Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.d e f

  • Risk of morphine toxicity in nursing infants of mothers taking codeine who are ultra-rapid metabolizers of codeine.104 105 106 113 Importance of monitoring infants for manifestations of morphine overdose (e.g., sedation, difficulty breathing, hypotonia, poor feeding); immediately seek medical attention if any symptoms develop.104 105 113

  • Importance of advising patients of other important precautionary information.d e (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Subject to control under the Federal Controlled Substances Act of 1970.d e

Codeine Phosphate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Bulk

Crystals

Bulk

Powder

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Acetaminophen and Codeine Phosphate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Solution

120 mg/5 mL Acetaminophen and Codeine Phosphate 12 mg/5 mL*

Acetaminophen and Codeine Phosphate Oral Solution (C-V)

Suspension

120 mg/5 mL Acetaminophen and Codeine Phosphate 12 mg/5 mL

Capital and Codeine (C-V)

Valeant

Tablets

300 mg Acetaminophen and Codeine Phosphate 15 mg*

Acetaminophen and Codeine Phosphate Tablets (C-III)

300 mg Acetaminophen and Codeine Phosphate 30 mg*

Acetaminophen and Codeine Phosphate Tablets (C-III)

Tylenol with Codeine No. 3 (C-III)

Janssen

300 mg Acetaminophen and Codeine Phosphate 60 mg*

Acetaminophen and Codeine Phosphate Tablets (C-III)

Tylenol with Codeine No. 4 (C-III)

Janssen

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Guaifenesin and Codeine Phosphate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Solution

100 mg/5 mL Guaifenesin and Codeine Phosphate 10 mg/5 mL*

Cheratussin AC (C-V)

Qualitest

Guaiatussin AC (C-V)

Hi-Tech

Guaifenesin AC Cough Syrup (C-V)

Guaifenesin and Codeine Phosphate Oral Solution (C-V)

Robafen AC (C-V)

Major

200 mg/5 mL Guaifenesin and Codeine Phosphate 8 mg/5 mL

Codar GF (C-V)

Respa

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Other Codeine Phosphate Combinations

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Capsules

30 mg with Acetaminophen 300 mg, Butalbital 50 mg, and Caffeine 40 mg

Fioricet with Codeine (C-III)

Watson

30 mg with Acetaminophen 325 mg, Butalbital 50 mg, and Caffeine 40 mg*

Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules (C-III)

30 mg with Aspirin 325 mg, Butalbital 50 mg, and Caffeine 40 mg*

Ascomp with Codeine (C-III)

Nexgen

Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules (C-III)

Fiorinal with Codeine (C-III)

Watson

Solution

6.33 mg/5 mL with Brompheniramine Maleate 1.33 mg/5 mL and Pseudoephedrine Hydrochloride 10 mg/5 mL

Rydex (C-V)

Centurion

8 mg/5 mL with Chlorpheniramine Maleate 2 mg/5 mL

Codar AR (C-V)

Respa

8 mg/5 mL with Chlorpheniramine Maleate 2 mg/5 mL and Pseudoephedrine Hydrochloride 30 mg/5 mL

Tricode AR (C-V)

Respa

8 mg/5 mL with Guaifenesin 200 mg/5 mL and Pseudoephedrine Hydrochloride 30 mg/5 mL

Tricode GF (C-V)

Respa

8 mg/5 mL with Pseudoephedrine Hydrochloride 30 mg/5 mL

Codar D (C-V)

Respa

9 mg/5 mL with Chlorcyclizine Hydrochloride 12.5 mg/5 mL and Pseudoephedrine Hydrochloride 30 mg/5 mL

Statuss Green (C-V)

Magna

9 mg/5 mL with Chlorpheniramine Maleate 2 mg/5 mL

Z-Tuss AC (C-V)

Magna

9 mg/5 mL with Dexchlorpheniramine Maleate 1 mg/5 mL and Phenylephrine Hydrochloride 5 mg/5 mL

Pro-Red AC (C-V)

Pro-Pharma

9 mg/5 mL with Guaifenesin 200 mg/5 mL and Pseudoephedrine Hydrochloride 30 mg/5 mL

Z-Tuss E (C-V)

Magna

9 mg/5 mL with Pyrilamine Maleate 8.33 mg/5 mL

Pro-Clear AC (C-V)

Pro-Pharma

10 mg/5 mL with Brompheniramine Maleate 4 mg/5 mL and Phenylephrine Hydrochloride 7.5 mg/5 mL

Poly-tussin AC (C-V)

Poly

10 mg/5 mL with Chlorcyclizine Hydrochloride 9.375 mg/5 mL

Poly-tussin (C-V)

Poly

10 mg/5 mL with Chlorcyclizine Hydrochloride 9.375 mg/5 mL and Pseudoephedrine Hydrochloride 30 mg/5 mL

Poly-tussin D (C-V)

Poly

10 mg/5 mL with Chlorpheniramine Maleate 2 mg/5 mL

EndaCof-C (C-V)

Larken

10 mg/5 mL with Guaifenesin 100 mg/5 mL and Pseudoephedrine Hydrochloride 22.5 mg/5 mL

Lortuss EX (C-V)

Poly

10 mg/5 mL with Guaifenesin 100 mg/5 mL and Pseudoephedrine Hydrochloride 30 mg/5 mL*

Cheratussin DAC (C-V)

Qualitest

Guaifenesin DAC Syrup (C-V)

10 mg/5 mL with Phenylephrine Hydrochloride 5 mg/5 mL and Promethazine Hydrochloride 6.25 mg/5 mL*

Promethazine VC with Codeine Syrup (C-V)

10 mg/5 mL with Phenylephrine Hydrochloride 7.5 mg/5 mL

Ala-Hist AC (C-V)

Poly

10 mg/5 mL with Promethazine Hydrochloride 6.25 mg/5 mL*

Promethazine Hydrochloride with Codeine Phosphate Oral Solution (C-V)

10 mg/5 mL with Pseudoephedrine Hydrochloride 30 mg/5 mL and Pyrilamine Maleate 15 mg/5 mL

Neo AC (C-V)

Laser

10 mg/5 mL with Pseudoephedrine Hydrochloride 30 mg/5 mL and Triprolidine Hydrochloride 1.25 mg/5 mL

Triacin-C (C-V)

STI Pharma

Tablets

16 mg with Aspirin 325 mg and Carisoprodol 200 mg*

Carisoprodol, Aspirin, and Codeine Phosphate Tablets (C-III)

Soma Compound with Codeine (C-III)

Meda

Also commercially available in combination with other antihistamines, decongestants, and expectorants.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Codeine Sulfate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Bulk

Powder

Oral

Solution

30 mg/5 mL*

Codeine Sulfate Oral Solution (C-II)

Tablets

15 mg*

Codeine Sulfate Tablets (C-II)

30 mg*

Codeine Sulfate Tablets (C-II)

60 mg*

Codeine Sulfate Tablets (C-II)

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 05/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Acetaminophen-Codeine 120-12MG/5ML Solution (MORTON GROVE PHARMACEUTICALS): 240/$19.99 or 720/$35.97

Acetaminophen-Codeine #2 300-15MG Tablets (TEVA PHARMACEUTICALS USA): 30/$14.99 or 60/$19.97

Acetaminophen-Codeine #3 300-30MG Tablets (MALLINCKRODT PHARM): 30/$15.99 or 60/$20.98

Acetaminophen-Codeine #4 300-60MG Tablets (MALLINCKRODT PHARM): 30/$17.99 or 90/$33.97

Carisoprodol-Aspirin-Codeine 200-325-16MG Tablets (SANDOZ): 30/$82.99 or 90/$235.96

Cheratussin AC 100-10MG/5ML Syrup (QUALITEST): 118/$12.99 or 354/$19.97

Cheratussin AC 100-10MG/5ML Syrup (QUALITEST): 473/$15.99 or 1419/$25.97

Cheratussin DAC 30-10-100MG/5ML Solution (QUALITEST): 473/$35.99 or 946/$60.97

Codeine Sulfate 30MG Tablets (ROXANE): 20/$19.99 or 30/$26.98

Guaifenesin-Codeine 100-10MG/5ML Solution (PHARMACEUTICAL ASSOCIATES): 473/$14.99 or 946/$18.97

Mytussin DAC 30-10-100MG/5ML Solution (MORTON GROVE PHARMACEUTICALS): 473/$39.66 or 1419/$118.98

Promethazine-Codeine 6.25-10MG/5ML Syrup (QUALITEST): 90/$13.99 or 120/$15.97

Tylenol with Codeine #4 300-60MG Tablets (MCNEIL): 30/$45.99 or 90/$119.97

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions April 23, 2014. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

Only references cited for selected revisions after 1984 are available electronically.

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d. Roxane Laboratories. Codeine sulfate tablets prescribing information. Columbus, OH. 2001 Jul.

e. Roxane Laboratories. Codeine sulfate oral solution prescribing information. Columbus, OH. 2000 Dec.

f. Ortho-McNeil. Tylenol with Codeine (acetaminophen and codeine phosphate) tablets prescribing information. In: Physicians’ desk reference. 56th ed. Montvale, NJ: Medical Economics Company Inc; 2002: 2595-6.

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h. USPDI: Drug information for the health care professional. Johnson KW, ed. 23th ed. Greenwood Village CO: Micromedex; 2003;2068-70.

i. Monarch Pharmaceuticals. Nucofed (codeine phosphate, pseudoephedrine hydrochloride, and guaifenesin) expectorant syrup. Bristol, TN; 1998 Sep.

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