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

ACETAMINOPHEN AND CODEINE PHOSPHATE vs ACETAMINOPHEN ASPIRIN AND CAFFEINE 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 AND CODEINE PHOSPHATE vs ACETAMINOPHEN, ASPIRIN AND CAFFEINE

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

View ACETAMINOPHEN AND CODEINE PHOSPHATE Monograph View ACETAMINOPHEN, ASPIRIN AND CAFFEINE Monograph
ACETAMINOPHEN AND CODEINE PHOSPHATE
Opioid Agonist
Category D/X
ACETAMINOPHEN, ASPIRIN AND CAFFEINE
NSAID / Antiplatelet
Category D/X
TL;DR — Key Differences
  • Drug class: ACETAMINOPHEN AND CODEINE PHOSPHATE is a Opioid Agonist; ACETAMINOPHEN, ASPIRIN AND CAFFEINE is a NSAID / Antiplatelet.
  • Half-life: ACETAMINOPHEN AND CODEINE PHOSPHATE has a half-life of 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.; ACETAMINOPHEN, ASPIRIN AND CAFFEINE has 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)..
  • No direct drug-drug interaction has been documented between ACETAMINOPHEN AND CODEINE PHOSPHATE and ACETAMINOPHEN, ASPIRIN AND CAFFEINE.
  • Pregnancy: ACETAMINOPHEN AND CODEINE PHOSPHATE is rated Category D/X; ACETAMINOPHEN, ASPIRIN AND CAFFEINE is rated Category D/X.

Last clinically reviewed: July 2026 · OpiCalc Medical Review Team

Clinical Essentials

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

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.

Indications
ACETAMINOPHEN AND CODEINE PHOSPHATE

Mild to moderate pain,Pain accompanied by fever

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.

Standard Dosing
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.

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.

Direct Interaction
ACETAMINOPHEN AND CODEINE PHOSPHATE
No Direct Interaction
ACETAMINOPHEN, ASPIRIN AND CAFFEINE
No Direct Interaction

Pharmacokinetics

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

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).

Metabolism
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.

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.

Excretion
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.

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.

Protein Binding
ACETAMINOPHEN AND CODEINE PHOSPHATE

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

ACETAMINOPHEN, ASPIRIN AND CAFFEINE

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

VD (L/kg)
ACETAMINOPHEN AND CODEINE PHOSPHATE

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

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.

Bioavailability
ACETAMINOPHEN AND CODEINE PHOSPHATE

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

ACETAMINOPHEN, ASPIRIN AND CAFFEINE

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

Special Populations

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

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.

Hepatic Adjustments
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.

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.

Pediatric Dosing
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.

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.

Geriatric Dosing
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.

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.

Safety & Monitoring

ACETAMINOPHEN AND CODEINE PHOSPHATE
ACETAMINOPHEN, ASPIRIN AND CAFFEINE
Black Box Warnings
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.

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.

Warnings/Precautions
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.

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.

Contraindications
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.

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.

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

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

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.

Pregnancy & Lactation

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

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.

Lactation Summary
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.

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.

Pregnancy Dosing
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.

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).

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

Clinical Insights

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

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.

Patient Counseling
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.

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.

Safety Verification

Known Interactions

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."

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."

Compare Alternatives

Related Drug Comparisons

Explore head-to-head clinical comparisons of other medications in the same therapeutic classes.

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Clinical Q&A

Frequently Asked Questions

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

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

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.. 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.. They differ in pharmacokinetic profiles, FDA-approved indications, and side effect profiles.

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

Potency comparisons between ACETAMINOPHEN AND CODEINE PHOSPHATE and ACETAMINOPHEN, ASPIRIN AND CAFFEINE 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 AND CODEINE PHOSPHATE vs ACETAMINOPHEN, ASPIRIN AND CAFFEINE?

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.. 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.. Dosing should always be individualized based on indication, renal and hepatic function, age, and other patient factors.

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

No direct drug-drug interaction has been formally documented between ACETAMINOPHEN AND CODEINE PHOSPHATE and ACETAMINOPHEN, ASPIRIN AND CAFFEINE in current clinical databases. However, individual patient risk factors including other medications, organ function, and comorbidities should always be evaluated by a qualified healthcare provider.

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

The maternal-fetal safety profiles differ. 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. 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 . Always consult a maternal-fetal medicine specialist before taking either drug during pregnancy or lactation.