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Peer-Reviewed Evidence
HomeDrug RegistryCompareACETAMINOPHEN ASPIRIN AND CAFFEINE vs ACETAMINOPHEN AND CODEINE PHOSPHATE
Comparative Pharmacology

ACETAMINOPHEN ASPIRIN AND CAFFEINE vs ACETAMINOPHEN AND CODEINE PHOSPHATE Comparison

Head-to-head clinical analysis & difference comparison: details on mechanism of action, dosing, half-life, interactions, and maternal-fetal safety.

Clinical EssentialsPharmacokineticsSpecial PopulationsSafety & MonitoringPregnancy & LactationClinical Insights
Differential Analysis

ACETAMINOPHEN, ASPIRIN AND CAFFEINE vs ACETAMINOPHEN AND CODEINE PHOSPHATE

Clinician-reviewed, head-to-head comparison of mechanism, dosing, pharmacokinetics, and safety profiles.

View ACETAMINOPHEN, ASPIRIN AND CAFFEINE Monograph View ACETAMINOPHEN AND CODEINE PHOSPHATE Monograph
ACETAMINOPHEN, ASPIRIN AND CAFFEINE
NSAID / Antiplatelet
Category D/X
ACETAMINOPHEN AND CODEINE PHOSPHATE
Opioid Agonist
Category D/X
TL;DR — Key Differences
  • Drug class: ACETAMINOPHEN, ASPIRIN AND CAFFEINE is a NSAID / Antiplatelet; ACETAMINOPHEN AND CODEINE PHOSPHATE is a Opioid Agonist.
  • Half-life: ACETAMINOPHEN, ASPIRIN AND CAFFEINE has a half-life of Acetaminophen: 2-4 hours (prolonged in liver disease); aspirin: 15-20 minutes (active metabolite salicylate: 2-3 hours at low doses, prolonged to 15-30 hours at high doses); caffeine: 3-6 hours (prolonged in pregnancy, liver disease).; ACETAMINOPHEN AND CODEINE PHOSPHATE has Acetaminophen: 2–3 hours (prolonged in hepatic impairment). Codeine: 2.5–3.5 hours; metabolites: morphine 1.5–2.5 hours, codeine-6-glucuronide 3–4 hours. Clinical context: dosing interval every 4–6 hours..
  • Direct interaction: A moderate interaction exists when combining these agents.
  • Pregnancy: ACETAMINOPHEN, ASPIRIN AND CAFFEINE is rated Category D/X; ACETAMINOPHEN AND CODEINE PHOSPHATE is rated Category D/X.

Last clinically reviewed: July 2026 · OpiCalc Medical Review Team

Clinical Essentials

ACETAMINOPHEN, ASPIRIN AND CAFFEINE
ACETAMINOPHEN AND CODEINE PHOSPHATE
Mechanism of Action
ACETAMINOPHEN, ASPIRIN AND CAFFEINE

Acetaminophen: weak COX-1/2 inhibitor, analgesic and antipyretic through central action; Aspirin: irreversible COX-1/2 inhibitor, anti-inflammatory, analgesic, antipyretic, antiplatelet; Caffeine: adenosine receptor antagonist, CNS stimulant, enhances analgesic effect.

ACETAMINOPHEN AND CODEINE PHOSPHATE

Acetaminophen: centrally acting analgesic and antipyretic, possibly via inhibition of cyclooxygenase (COX) and modulation of cannabinoid receptors. Codeine: prodrug converted to morphine; mu-opioid receptor agonist.

Indications
ACETAMINOPHEN, ASPIRIN AND CAFFEINE

FDA-approved: Temporary relief of minor aches and pains (headache, muscle ache, toothache, backache, menstrual cramps), reduction of fever.,Off-label: None commonly accepted.

ACETAMINOPHEN AND CODEINE PHOSPHATE

Mild to moderate pain,Pain accompanied by fever

Standard Dosing
ACETAMINOPHEN, ASPIRIN AND CAFFEINE

1-2 tablets (250 mg acetaminophen, 250 mg aspirin, 65 mg caffeine per tablet) orally every 4-6 hours as needed for pain or fever; maximum 8 tablets per 24 hours.

ACETAMINOPHEN AND CODEINE PHOSPHATE

One or two tablets (acetaminophen 300 mg/codeine 30 mg per tablet) orally every 4-6 hours as needed for pain; maximum 12 tablets daily.

Direct Interaction
ACETAMINOPHEN, ASPIRIN AND CAFFEINE
MODERATE Risk
ACETAMINOPHEN AND CODEINE PHOSPHATE
MODERATE Risk

Pharmacokinetics

ACETAMINOPHEN, ASPIRIN AND CAFFEINE
ACETAMINOPHEN AND CODEINE PHOSPHATE
Half-Life
ACETAMINOPHEN, ASPIRIN AND CAFFEINE

Acetaminophen: 2-4 hours (prolonged in liver disease); aspirin: 15-20 minutes (active metabolite salicylate: 2-3 hours at low doses, prolonged to 15-30 hours at high doses); caffeine: 3-6 hours (prolonged in pregnancy, liver disease).

ACETAMINOPHEN AND CODEINE PHOSPHATE

Acetaminophen: 2–3 hours (prolonged in hepatic impairment). Codeine: 2.5–3.5 hours; metabolites: morphine 1.5–2.5 hours, codeine-6-glucuronide 3–4 hours. Clinical context: dosing interval every 4–6 hours.

Metabolism
ACETAMINOPHEN, ASPIRIN AND CAFFEINE

Acetaminophen: primarily hepatic via glucuronidation (UGT1A1, UGT1A6, UGT1A9), sulfation (SULT1A1), and minor CYP2E1 (toxic metabolite NAPQI); Aspirin: hydrolyzed to salicylate, further metabolized by conjugation (glycine, glucuronic acid) and oxidation; Caffeine: hepatic via CYP1A2 (major), CYP2E1, CYP3A4, N-acetyltransferase.

ACETAMINOPHEN AND CODEINE PHOSPHATE

Acetaminophen: primarily glucuronidation and sulfation in liver; minor CYP450 (CYP2E1) to toxic NAPQI. Codeine: CYP2D6 to morphine; CYP3A4 to norcodeine; glucuronidation.

Excretion
ACETAMINOPHEN, ASPIRIN AND CAFFEINE

Acetaminophen: renal elimination of metabolites (glucuronide 60%, sulfate 30%, cysteine/mercapturate 8%, unchanged 2%); aspirin: renal elimination of salicylate and metabolites (75% salicyluric acid, 10% glucuronides, 10% salicylate); caffeine: renal elimination of metabolites (paraxanthine, theobromine, theophylline; <3% unchanged). Total: >95% renal.

ACETAMINOPHEN AND CODEINE PHOSPHATE

Acetaminophen: renal elimination of conjugated metabolites (glucuronide 60%, sulfate 30%, cysteine/mercapturate <5%), less than 5% unchanged. Codeine: renal elimination of codeine (5–15%), morphine (5–10%), norcodeine (10–20%), and conjugates; 90% excreted in urine within 24 hours.

Protein Binding
ACETAMINOPHEN, ASPIRIN AND CAFFEINE

Acetaminophen: 10-25% (albumin); aspirin: 80-90% (albumin, decreased at high doses); caffeine: 35% (albumin).

ACETAMINOPHEN AND CODEINE PHOSPHATE

Acetaminophen: 10–25% (albumin). Codeine: 7–25% (primarily albumin).

VD (L/kg)
ACETAMINOPHEN, ASPIRIN AND CAFFEINE

Acetaminophen: 0.9-1.0 L/kg; aspirin: 0.15-0.2 L/kg (low); caffeine: 0.6-0.8 L/kg. Reflects distribution into total body water.

ACETAMINOPHEN AND CODEINE PHOSPHATE

Acetaminophen: 0.9 L/kg. Codeine: 3–6 L/kg (extensive tissue distribution).

Bioavailability
ACETAMINOPHEN, ASPIRIN AND CAFFEINE

Acetaminophen: oral 85-98%; aspirin: oral 50-80% (due to first-pass hydrolysis); caffeine: oral ~100%.

ACETAMINOPHEN AND CODEINE PHOSPHATE

Oral: acetaminophen 88% (variable first-pass); codeine 50–60% (first-pass metabolism to morphine, norcodeine, and conjugates).

Special Populations

ACETAMINOPHEN, ASPIRIN AND CAFFEINE
ACETAMINOPHEN AND CODEINE PHOSPHATE
Renal Adjustments
ACETAMINOPHEN, ASPIRIN AND CAFFEINE

Contraindicated in severe renal impairment (Cr Cl <10 m L/min). For Cr Cl 10-50 m L/min: avoid aspirin component; consider alternative therapy. For Cr Cl >50 m L/min: no adjustment needed for acetaminophen; aspirin may require dose reduction or monitoring.

ACETAMINOPHEN AND CODEINE PHOSPHATE

GFR 30-50 m L/min: administer every 6 hours; GFR 10-29 m L/min: administer every 8 hours; GFR <10 m L/min: administer every 12 hours; hemodialysis: not recommended.

Hepatic Adjustments
ACETAMINOPHEN, ASPIRIN AND CAFFEINE

Child-Pugh A: caution with acetaminophen (max 2 g/day) and avoid caffeine if severe. Child-Pugh B: avoid aspirin; reduce acetaminophen dose (max 2 g/day) and limit caffeine. Child-Pugh C: contraindicated due to aspirin and acetaminophen risk.

ACETAMINOPHEN AND CODEINE PHOSPHATE

Child-Pugh A: no adjustment; Child-Pugh B: reduce dose by 50% and extend interval to every 8 hours; Child-Pugh C: contraindicated.

Pediatric Dosing
ACETAMINOPHEN, ASPIRIN AND CAFFEINE

Not recommended for children <12 years due to aspirin risk of Reye's syndrome. For adolescents ≥12 years: same as adult dosing: 1-2 tablets every 4-6 hours, max 8 tablets/24 hours.

ACETAMINOPHEN AND CODEINE PHOSPHATE

For children ≥12 years: acetaminophen 10-15 mg/kg/dose and codeine 0.5-1 mg/kg/dose orally every 4-6 hours; maximum acetaminophen 75 mg/kg/day, codeine 6 mg/kg/day. For children <12 years: not recommended due to codeine safety concerns.

Geriatric Dosing
ACETAMINOPHEN, ASPIRIN AND CAFFEINE

Caution due to increased sensitivity to aspirin (GI bleeding, renal impairment) and caffeine (insomnia, tachycardia). Start at low end of dosing: 1 tablet every 6 hours; monitor renal function and avoid long-term use.

ACETAMINOPHEN AND CODEINE PHOSPHATE

Start with lowest effective dose; acetaminophen component maximum 3 g/day; consider reduced codeine dose (e.g., 15 mg) due to increased sensitivity and risk of respiratory depression; extend dosing interval to every 6-8 hours.

Safety & Monitoring

ACETAMINOPHEN, ASPIRIN AND CAFFEINE
ACETAMINOPHEN AND CODEINE PHOSPHATE
Black Box Warnings
ACETAMINOPHEN, ASPIRIN AND CAFFEINE
FDA Black Box Warning

Reye syndrome warning: Aspirin should not be used in children or teenagers with viral illnesses due to risk of Reye syndrome.

ACETAMINOPHEN AND CODEINE PHOSPHATE
FDA Black Box Warning

Risk of medication errors: confusion between milligram and milliliter doses, and between codeine and acetaminophen components. Contraindicated for postoperative pain management in children following tonsillectomy/adenoidectomy due to risk of respiratory depression and death.

Warnings/Precautions
ACETAMINOPHEN, ASPIRIN AND CAFFEINE

Hepatotoxicity (acetaminophen overdose), gastrointestinal bleeding (aspirin), Reye syndrome (aspirin in children with viral illness), cardiovascular risk (aspirin may increase bleeding), caffeine-related CNS stimulation, risk of dependence.

ACETAMINOPHEN AND CODEINE PHOSPHATE

Hepatotoxicity (acetaminophen overdose); respiratory depression; drug dependence; ultra-rapid metabolizers of codeine (CYP2D6) leading to morphine toxicity; concomitant CNS depressants; use in pediatric patients; avoid alcohol.

Contraindications
ACETAMINOPHEN, ASPIRIN AND CAFFEINE

Hypersensitivity to any component; active peptic ulcer disease; bleeding disorders; severe hepatic impairment; children/adolescents with viral illness (Reye syndrome); third trimester of pregnancy (aspirin); concurrent use of other salicylates or NSAIDs; severe renal impairment.

ACETAMINOPHEN AND CODEINE PHOSPHATE

Hypersensitivity to acetaminophen or codeine; severe respiratory depression; acute or severe asthma; paralytic ileus; post-operative pain management in children after tonsillectomy/adenoidectomy; breastfeeding (in ultra-rapid metabolizers); concomitant MAOIs.

Adverse Reactions
ACETAMINOPHEN, ASPIRIN AND CAFFEINE
Data Pending
ACETAMINOPHEN AND CODEINE PHOSPHATE
Data Pending
Food Interactions
ACETAMINOPHEN, ASPIRIN AND CAFFEINE

Alcohol increases risk of hepatotoxicity with acetaminophen and GI bleeding with aspirin. Caffeine-containing foods or beverages should be limited to avoid excessive caffeine intake. High-tyramine foods (e.g., aged cheeses, cured meats) may potentiate caffeine effects; no significant interaction documented.

ACETAMINOPHEN AND CODEINE PHOSPHATE

Avoid alcohol; high-fat meals may delay absorption but not clinically significant.

Pregnancy & Lactation

ACETAMINOPHEN, ASPIRIN AND CAFFEINE
ACETAMINOPHEN AND CODEINE PHOSPHATE
Teratogenic Risk
ACETAMINOPHEN, ASPIRIN AND CAFFEINE

First trimester: Aspirin is associated with increased risk of neural tube defects and cardiac malformations; acetaminophen is considered low risk but some studies suggest possible association with gastroschisis. Second trimester: Aspirin may increase risk of intracranial hemorrhage; acetaminophen and caffeine generally not linked to major malformations. Third trimester: Aspirin use is contraindicated due to risk of premature ductus arteriosus closure and oligohydramnios; high-dose acetaminophen may cause oligohydramnios; caffeine metabolism slows, but moderate intake appears safe; chronic high-dose caffeine may be associated with low birth weight.

ACETAMINOPHEN AND CODEINE PHOSPHATE

Acetaminophen is considered low risk in all trimesters at therapeutic doses; chronic high doses may be associated with adverse outcomes. Codeine is associated with risk of respiratory depression and neonatal withdrawal if used near term; may cause neural tube defects and other malformations with first-trimester exposure, but data are conflicting. Use lowest effective dose for shortest duration.

Lactation Summary
ACETAMINOPHEN, ASPIRIN AND CAFFEINE

Acetaminophen: M/P ratio approximately 0.9; small amounts excreted; considered safe. Aspirin: M/P ratio variable, typically 0.12-0.42; avoid high doses due to risk of Reye's syndrome; single doses unlikely harmful. Caffeine: M/P ratio approximately 0.5-1.0; moderate intake (≤300 mg/day) considered safe; excessive intake may cause irritability in infant.

ACETAMINOPHEN AND CODEINE PHOSPHATE

Acetaminophen is excreted into breast milk in low amounts (M/P ratio ~0.91-1.42) and is considered compatible with breastfeeding. Codeine is also excreted in breast milk; risk of infant opioid toxicity depends on maternal CYP2D6 phenotype. Ultra-rapid metabolizers may produce higher morphine levels. Use with caution, avoid in known CYP2D6 ultra-rapid metabolizers, and monitor infant for sedation and respiratory depression.

Pregnancy Dosing
ACETAMINOPHEN, ASPIRIN AND CAFFEINE

Acetaminophen: No dose adjustment needed; standard dosing (650-1000 mg every 4-6 hours, max 3000 mg/day). Aspirin: Avoid doses >81 mg/day in third trimester; use lowest effective dose. Caffeine: Metabolism prolonged; limit to ≤200 mg/day (approximately 2 cups coffee).

ACETAMINOPHEN AND CODEINE PHOSPHATE

No routine dose adjustment needed for acetaminophen. Codeine pharmacokinetics are altered in pregnancy: increased clearance and volume of distribution may require dose adjustment; however, due to variability in CYP2D6 metabolism, individualize dosing and monitor for efficacy and toxicity. Avoid codeine in pregnancy unless alternative analgesics are ineffective.

Maternal Safety Status
ACETAMINOPHEN, ASPIRIN AND CAFFEINE
Category D/X
ACETAMINOPHEN AND CODEINE PHOSPHATE
Category D/X

Clinical Insights

ACETAMINOPHEN, ASPIRIN AND CAFFEINE
ACETAMINOPHEN AND CODEINE PHOSPHATE
Clinical Pearls
ACETAMINOPHEN, ASPIRIN AND CAFFEINE

Acetaminophen, aspirin, and caffeine combination is used for mild to moderate pain and fever reduction. Aspirin component provides anti-inflammatory effects; caution in patients with bleeding disorders or those on anticoagulants due to increased bleeding risk. Acetaminophen hepatotoxicity risk with doses >4g/day or in liver disease. Caffeine may cause insomnia, tremor, or palpitations; avoid in patients with anxiety disorders. Reye syndrome risk with aspirin use in children with viral illnesses. Monitor renal function in elderly or dehydrated patients.

ACETAMINOPHEN AND CODEINE PHOSPHATE

For acute pain, limit codeine to 3 days; avoid in children under 12 due to CYP2D6 ultra-rapid metabolizer risk of fatal respiratory depression; monitor for constipation; assess liver function for acetaminophen hepatotoxicity; use with caution in renal impairment.

Patient Counseling
ACETAMINOPHEN, ASPIRIN AND CAFFEINE

Do not exceed recommended dose; acetaminophen overdose can cause liver damage.,Avoid alcohol while taking this medication.,Do not use in children or teenagers with viral illnesses due to Reye syndrome risk.,May cause stomach upset; take with food or milk.,Limit caffeine intake from other sources when using this medication.

ACETAMINOPHEN AND CODEINE PHOSPHATE

Take exactly as prescribed; do not exceed 4000 mg acetaminophen per day.,Avoid alcohol while taking this medication.,Do not use with other acetaminophen-containing products.,May cause dizziness or drowsiness; avoid driving until you know how you react.,Common side effects include constipation, nausea, and drowsiness.,Seek emergency if signs of allergic reaction or difficulty breathing occur.

Safety Verification

Known Interactions

ACETAMINOPHEN, ASPIRIN AND CAFFEINE Risks3
Triamterene + Caffeine
moderate

"Triamterene, a potassium-sparing diuretic, can inhibit the hepatic metabolism of caffeine by competing for cytochrome P450 (CYP) 1A2, the primary enzyme responsible for caffeine clearance. This leads to increased plasma caffeine concentrations and prolonged caffeine half-life, potentially causing caffeine toxicity manifesting as nervousness, insomnia, tachycardia, and diuresis enhancement. Patients may experience exaggerated stimulant effects and increased risk of cardiac arrhythmias when combining these agents."

Caffeine + Sulfadiazine
moderate

"Caffeine inhibits the metabolism of sulfadiazine by competitively antagonizing cytochrome P450 (CYP) enzymes, particularly CYP1A2, leading to increased plasma concentrations of sulfadiazine. This elevates the risk of dose-dependent adverse effects, including crystalluria, nephrotoxicity, and hypersensitivity reactions. The interaction may also reduce the therapeutic efficacy of sulfadiazine due to altered pharmacokinetics."

Caffeine + Losartan
moderate

"Caffeine inhibits the cytochrome P450 enzyme CYP2C9, which is primarily responsible for the metabolism of losartan to its active metabolite E-3174. This inhibition can lead to increased plasma concentrations of losartan and decreased formation of the active metabolite, potentially reducing losartan's antihypertensive efficacy. The clinical outcome may be suboptimal blood pressure control in patients consuming high amounts of caffeine."

ACETAMINOPHEN AND CODEINE PHOSPHATE Risks3
Pirenzepine + Codeine
moderate

"Pirenzepine, a selective M1 muscarinic antagonist, reduces gastrointestinal motility and secretions, while codeine, an opioid agonist, also decreases gastrointestinal motility via mu-opioid receptors. Concurrent use leads to additive anticholinergic and opioid effects, resulting in enhanced risk of severe constipation, paralytic ileus, and central nervous system depression. Clinically, patients may experience exacerbated sedation, respiratory depression, and urinary retention."

Ropinirole + Codeine
moderate

"Ropinirole, a non-ergoline dopamine agonist used in Parkinson's disease and restless legs syndrome, may reduce the analgesic efficacy of codeine. This is likely due to pharmacodynamic antagonism at central dopamine and opioid receptors, as well as potential pharmacokinetic interactions that decrease the conversion of codeine to its active metabolite morphine via CYP2D6 inhibition by ropinirole. The resultant blunted opioid response can lead to inadequate pain control, necessitating dose adjustment or alternative therapy."

Vemurafenib + Codeine
moderate

"Vemurafenib induces CYP3A4, significantly reducing the plasma concentrations of codeine, which is metabolized via CYP3A4 to its active metabolite morphine. This may diminish codeine's analgesic efficacy, potentially leading to inadequate pain control. Additionally, reduced formation of morphine may lower the risk of opioid-related adverse effects."

Compare Alternatives

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Clinical Q&A

Frequently Asked Questions

Common clinical questions about ACETAMINOPHEN, ASPIRIN AND CAFFEINE vs ACETAMINOPHEN AND CODEINE PHOSPHATE, answered by our medical review team.

1. What is the main difference between ACETAMINOPHEN, ASPIRIN AND CAFFEINE and ACETAMINOPHEN AND CODEINE PHOSPHATE?

ACETAMINOPHEN, ASPIRIN AND CAFFEINE is a NSAID / Antiplatelet that works by Acetaminophen: weak COX-1/2 inhibitor, analgesic and antipyretic through central action; Aspirin: irreversible COX-1/2 inhibitor, anti-inflammatory, analgesic, antipyretic, antiplatelet; Caffeine: adenosine receptor antagonist, CNS stimulant, enhances analgesic effect.. ACETAMINOPHEN AND CODEINE PHOSPHATE is a Opioid Agonist that works by Acetaminophen: centrally acting analgesic and antipyretic, possibly via inhibition of cyclooxygenase (COX) and modulation of cannabinoid receptors. Codeine: prodrug converted to morphine; mu-opioid receptor agonist.. They differ in pharmacokinetic profiles, FDA-approved indications, and side effect profiles.

2. Which is stronger: ACETAMINOPHEN, ASPIRIN AND CAFFEINE or ACETAMINOPHEN AND CODEINE PHOSPHATE?

Potency comparisons between ACETAMINOPHEN, ASPIRIN AND CAFFEINE and ACETAMINOPHEN AND CODEINE PHOSPHATE depend on the specific clinical indication. These are agents from distinct pharmacological classes and are not directly interchangeable by dose. A physician or clinical pharmacist should guide any therapeutic switching decisions.

3. What is the standard dosing for ACETAMINOPHEN, ASPIRIN AND CAFFEINE vs ACETAMINOPHEN AND CODEINE PHOSPHATE?

The standard adult dose of ACETAMINOPHEN, ASPIRIN AND CAFFEINE is: 1-2 tablets (250 mg acetaminophen, 250 mg aspirin, 65 mg caffeine per tablet) orally every 4-6 hours as needed for pain or fever; maximum 8 tablets per 24 hours.. The standard adult dose of ACETAMINOPHEN AND CODEINE PHOSPHATE is: One or two tablets (acetaminophen 300 mg/codeine 30 mg per tablet) orally every 4-6 hours as needed for pain; maximum 12 tablets daily.. Dosing should always be individualized based on indication, renal and hepatic function, age, and other patient factors.

4. Can you take ACETAMINOPHEN, ASPIRIN AND CAFFEINE and ACETAMINOPHEN AND CODEINE PHOSPHATE together?

A moderate-severity drug interaction has been identified when combining ACETAMINOPHEN, ASPIRIN AND CAFFEINE and ACETAMINOPHEN AND CODEINE PHOSPHATE. The metabolism of Caffeine can be decreased when combined with Acetaminophen. Consult your prescriber before combining these medications.

5. Are ACETAMINOPHEN, ASPIRIN AND CAFFEINE and ACETAMINOPHEN AND CODEINE PHOSPHATE safe during pregnancy?

The maternal-fetal safety profiles differ. ACETAMINOPHEN, ASPIRIN AND CAFFEINE is classified as Category D/X. First trimester: Aspirin is associated with increased risk of neural tube defects and cardiac malformations; acetaminophen is considered low risk but some studies suggest possible . ACETAMINOPHEN AND CODEINE PHOSPHATE is classified as Category D/X. Acetaminophen is considered low risk in all trimesters at therapeutic doses; chronic high doses may be associated with adverse outcomes. Codeine is associated with risk of respirat. Always consult a maternal-fetal medicine specialist before taking either drug during pregnancy or lactation.