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Registry Hub
Peer-Reviewed Evidence
HomeDrug RegistryCompareACETAMINOPHEN ASPIRIN AND CODEINE PHOSPHATE vs HY PHEN
Comparative Pharmacology

ACETAMINOPHEN ASPIRIN AND CODEINE PHOSPHATE vs HY PHEN 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 CODEINE PHOSPHATE vs HY-PHEN

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

View ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE Monograph View HY-PHEN Monograph
ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE
Opioid Agonist
Category D/X
HY-PHEN
Opioid Antitussive Combination
Category C
TL;DR — Key Differences
  • Drug class: ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE is a Opioid Agonist; HY-PHEN is a Opioid Antitussive Combination.
  • Half-life: ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE has a half-life of Acetaminophen: 2-3 hours (terminal). Aspirin: 15-30 minutes (parent drug); salicylate: 2-3 hours at low doses, 15-30 hours at high doses due to saturable metabolism. Codeine: 2.5-4 hours. Clinical context: Prolonged half-life of salicylate at high doses increases risk of toxicity; hepatic impairment prolongs acetaminophen and codeine half-lives.; HY-PHEN has 2-3 hours (terminal elimination half-life). Clinical context: Short half-life requires frequent dosing (every 4-6 hours) for sustained analgesic effect..
  • No direct drug-drug interaction has been documented between ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE and HY-PHEN.
  • Pregnancy: ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE is rated Category D/X; HY-PHEN is rated Category C.

Last clinically reviewed: July 2026 · OpiCalc Medical Review Team

Clinical Essentials

ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE
HY-PHEN
Mechanism of Action
ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE

Acetaminophen: cyclooxygenase (COX) inhibitor, primarily central, analgesic and antipyretic. Aspirin: irreversible COX-1 and COX-2 inhibitor, analgesic, anti-inflammatory, antipyretic, antiplatelet. Codeine: prodrug converted to morphine; mu-opioid receptor agonist.

HY-PHEN

HY-PHEN is a combination of hydrocodone (a mu-opioid receptor agonist) and acetaminophen (an analgesic and antipyretic). Hydrocodone binds to mu-opioid receptors in the CNS, altering pain perception and emotional response to pain. Acetaminophen inhibits cyclooxygenase (COX) enzymes, particularly in the CNS, reducing prostaglandin synthesis.

Indications
ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE

Mild to moderate pain,Fever (acetaminophen and aspirin),Inflammatory conditions (aspirin)

HY-PHEN

Management of moderate to moderately severe pain,Off-label: Acute pain, postoperative pain, chronic pain (limited use due to acetaminophen toxicity risk)

Standard Dosing
ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE

1-2 tablets (each containing acetaminophen 300 mg, aspirin 300 mg, codeine phosphate 30 mg) orally every 4-6 hours as needed for pain; maximum 8 tablets/day.

HY-PHEN

1-2 tablets (acetaminophen 500 mg/hydrocodone 5-10 mg) orally every 4-6 hours as needed for pain; maximum 8 tablets per day.

Direct Interaction
ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE
No Direct Interaction
HY-PHEN
No Direct Interaction

Pharmacokinetics

ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE
HY-PHEN
Half-Life
ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE

Acetaminophen: 2-3 hours (terminal). Aspirin: 15-30 minutes (parent drug); salicylate: 2-3 hours at low doses, 15-30 hours at high doses due to saturable metabolism. Codeine: 2.5-4 hours. Clinical context: Prolonged half-life of salicylate at high doses increases risk of toxicity; hepatic impairment prolongs acetaminophen and codeine half-lives.

HY-PHEN

2-3 hours (terminal elimination half-life). Clinical context: Short half-life requires frequent dosing (every 4-6 hours) for sustained analgesic effect.

Metabolism
ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE

Acetaminophen: hepatic via CYP2E1, CYP1A2, CYP3A4; glucuronidation and sulfation; NAPQI formation. Aspirin: hepatic hydrolysis to salicylate; conjugation with glycine and glucuronic acid. Codeine: hepatic via CYP2D6 to morphine (active); also via CYP3A4 to norcodeine.

HY-PHEN

Hydrocodone is metabolized via CYP3A4 to hydromorphone (active) and via CYP2D6 to norhydrocodone. Acetaminophen is primarily metabolized via glucuronidation and sulfation; a minor pathway via CYP2E1 produces a hepatotoxic metabolite (NAPQI) that is normally detoxified by glutathione.

Excretion
ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE

Acetaminophen: renal excretion of metabolites (glucuronide and sulfate conjugates, ~85-90%), minor parent drug (<5%). Aspirin: renal excretion of salicylate and its metabolites (salicyluric acid, glucuronides, gentisic acid), dose-dependent; at therapeutic doses, ~50-80% as free salicylate and conjugates. Codeine: renal excretion of free and conjugated codeine (about 90%) and metabolites (morphine, norcodeine).

HY-PHEN

Renal (primarily as glucuronide conjugates and unchanged drug). Approximately 90-95% eliminated in urine within 24 hours; fecal excretion <5%.

Protein Binding
ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE

Acetaminophen: 10-25% (albumin). Aspirin: 50-80% (albumin), dose-dependent; salicylate: 75-90% (albumin). Codeine: ~7% (albumin).

HY-PHEN

25-35% bound to plasma proteins (mainly albumin).

VD (L/kg)
ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE

Acetaminophen: 0.9-1.0 L/kg (large distribution including liver). Aspirin: 0.15-0.2 L/kg (low Vd, confined to plasma and extracellular fluid); salicylate: 0.2-0.3 L/kg. Codeine: 3-6 L/kg (extensive tissue distribution). Clinical meaning: Large Vd for codeine suggests extensive tissue binding; aspirin Vd is small, consistent with limited extravascular distribution.

HY-PHEN

0.9-1.5 L/kg. Clinical meaning: Moderate Vd indicates distribution into total body water; does not extensively accumulate in tissues.

Bioavailability
ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE

Oral: Acetaminophen: 85-95%. Aspirin: 40-60% (due to first-pass hydrolysis to salicylate). Codeine: ~50% due to first-pass metabolism.

HY-PHEN

Oral: 60-90% (first-pass metabolism reduces systemic availability); Rectal: 70-80%; IV/IM: 100%.

Special Populations

ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE
HY-PHEN
Renal Adjustments
ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE

GFR 30-59 m L/min: Administer every 6 hours; maximum 6 tablets/day. GFR 15-29 m L/min: Administer every 12 hours; maximum 4 tablets/day. GFR <15 m L/min: Not recommended due to accumulation of codeine metabolites.

HY-PHEN

GFR 30-50 m L/min: administer at 75% of usual dose every 6 hours; GFR <30 m L/min: administer at 50% of usual dose every 8 hours. Avoid in severe renal impairment.

Hepatic Adjustments
ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE

Child-Pugh Class A: No adjustment. Child-Pugh Class B: Reduce dose by 50% and extend interval to every 6 hours; maximum 4 tablets/day. Child-Pugh Class C: Contraindicated.

HY-PHEN

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

Pediatric Dosing
ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE

Not recommended for children <12 years due to aspirin risk of Reye syndrome. For children ≥12 years: Dose based on codeine component (0.5-1 mg/kg/dose) with maximum acetaminophen 75 mg/kg/day and aspirin 100 mg/kg/day. Typical: 1 tablet (acetaminophen 300 mg/aspirin 300 mg/codeine 30 mg) every 4-6 hours as needed; max 4 tablets/day.

HY-PHEN

Not recommended for children under 18 years due to risk of opioid-related adverse effects; alternative analgesics preferred.

Geriatric Dosing
ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE

Start with lowest effective dose (e.g., 1 tablet every 6 hours); monitor renal and hepatic function; maximum 6 tablets/day due to increased sensitivity and risk of adverse effects.

HY-PHEN

Initiate with lowest effective dose (e.g., acetaminophen 500 mg/hydrocodone 5 mg) every 6 hours; monitor for respiratory depression, constipation, and falls; may require dose reduction by 25-50% compared to younger adults.

Safety & Monitoring

ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE
HY-PHEN
Black Box Warnings
ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE
FDA Black Box Warning

Risk of medication errors: confusion between different strengths and concentrations of acetaminophen can result in accidental overdose and fatal hepatotoxicity. Aspirin use in children and teenagers with viral infections is associated with Reye's syndrome.

HY-PHEN
FDA Black Box Warning

Addiction, abuse, and misuse; life-threatening respiratory depression; accidental ingestion of acetaminophen (especially in children) can cause hepatotoxicity; neonatal opioid withdrawal syndrome with prolonged use during pregnancy; risks from concomitant use with benzodiazepines or other CNS depressants (additive respiratory depression).

Warnings/Precautions
ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE

Hepatotoxicity (acetaminophen dose >4 g/day), Reye's syndrome (aspirin in children), respiratory depression (codeine), tolerance/dependence, bleeding risk (aspirin), GI toxicity, renal impairment, hypersensitivity reactions.

HY-PHEN

Hepatotoxicity due to acetaminophen (dose-dependent); respiratory depression (especially in elderly, debilitated, or COPD); opioid-induced hyperalgesia; adrenal insufficiency; severe hypotension; seizures; serotonin syndrome with serotonergic drugs; urinary retention; bile duct spasm; use in patients with head injury or increased intracranial pressure (risk of masking neurological signs); neonatal withdrawal syndrome.

Contraindications
ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE

Hypersensitivity to any component, active peptic ulcer disease, bleeding disorders, severe hepatic impairment, severe respiratory depression, children with viral illness (aspirin), pregnancy (third trimester for aspirin, codeine cautious).

HY-PHEN

Significant respiratory depression; acute or severe bronchial asthma; known or suspected gastrointestinal obstruction (e.g., paralytic ileus); severe hepatic impairment; hypersensitivity to hydrocodone, acetaminophen, or any component; use of MAO inhibitors within 14 days (hypertensive crisis).

Adverse Reactions
ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE
Data Pending
HY-PHEN
Data Pending
Food Interactions
ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE

Avoid alcohol due to increased risk of acetaminophen hepatotoxicity and aspirin-induced GI bleeding. Avoid large amounts of caffeine or high-tyramine foods (e.g., aged cheeses, cured meats) as they may affect CYP2D6 metabolism of codeine.

HY-PHEN

Avoid alcohol consumption due to increased risk of hepatotoxicity and CNS depression. Grapefruit juice may inhibit CYP2D6 metabolism of hydrocodone, potentially altering analgesic effect; avoid concurrent use. High-fat meals may increase absorption of hydrocodone; take consistently with or without food.

Pregnancy & Lactation

ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE
HY-PHEN
Teratogenic Risk
ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE

Acetaminophen: Generally considered low risk; association with ASD and ADHD with prolonged use not fully established. Aspirin: First trimester: possible increased risk of gastroschisis; second trimester: relatively safe; third trimester: risk of premature closure of ductus arteriosus, oligohydramnios, and increased peripartum hemorrhage. Codeine: First trimester: possible neural tube defects; second and third trimesters: risk of respiratory depression, withdrawal in neonate with chronic use; neonatal opioid withdrawal syndrome (NOWS) possible.

HY-PHEN

Pregnancy Category C. First trimester: No well-controlled studies; potential for fetal harm based on animal studies (cleft palate, skeletal anomalies). Second and third trimesters: Prolonged use may cause neonatal withdrawal syndrome (irritability, hypertonia, respiratory depression) if used near term. Avoid use in pregnancy unless benefit outweighs risk.

Lactation Summary
ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE

Acetaminophen: M/P ratio approximately 0.91-1.42; considered safe. Aspirin: M/P ratio 0.08-0.15; high doses may cause Reye's syndrome; avoid or use low doses. Codeine: M/P ratio about 2.5; variable metabolism; risk of CNS depression in infant; avoid due to potential for toxicity in CYP2D6 ultrarapid metabolizers.

HY-PHEN

HY-PHEN (hydrocodone/acetaminophen) is excreted into breast milk in low concentrations. M/P ratio for hydrocodone is approximately 2.0, for acetaminophen ~1.0. Use caution; monitor infant for sedation, respiratory depression, and poor feeding. Consider risk of neonatal withdrawal if maternal use is chronic.

Pregnancy Dosing
ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE

Acetaminophen: No dose adjustment needed. Aspirin: Avoid in third trimester; use lowest effective dose if necessary. Codeine: Avoid in pregnancy; if used, lowest effective dose for shortest duration; caution for CYP2D6 polymorphism. Pharmacokinetic changes: Increased clearance of codeine during pregnancy may require higher doses but risk outweighs benefit.

HY-PHEN

No specific dose adjustments established for pregnancy. Increased plasma volume and enhanced hepatic metabolism in pregnancy may reduce drug concentrations, potentially requiring higher doses to achieve analgesic effect. However, avoid high doses due to risk of acetaminophen hepatotoxicity and fetal opioid exposure. Use lowest effective dose for shortest duration.

Maternal Safety Status
ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE
Category D/X
HY-PHEN
Category C

Clinical Insights

ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE
HY-PHEN
Clinical Pearls
ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE

Combination analgesic with acetaminophen (hepatotoxic at high doses), aspirin (antiplatelet, GI irritant, contraindicated in children <12 due to Reye's syndrome), and codeine (prodrug to morphine via CYP2D6; efficacy depends on CYP2D6 phenotype; risk of CNS/respiratory depression). Avoid in severe hepatic/renal impairment, active peptic ulcer, bleeding disorders, or concomitant use of other CNS depressants. Maximum acetaminophen dose from all sources: 4 g/day.

HY-PHEN

HY-PHEN is a combination of hydrocodone and acetaminophen. Monitor for acetaminophen hepatotoxicity; maximum daily acetaminophen dose should not exceed 4 g from all sources. Hydrocodone is a prodrug metabolized by CYP2D6 to hydromorphone; poor metabolizers may have reduced analgesia while ultra-rapid metabolizers risk toxicity. Avoid concurrent use with other CNS depressants including alcohol due to additive respiratory depression. Taper dose when discontinuing after prolonged use to prevent withdrawal.

Patient Counseling
ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE

Do not exceed recommended dose; acetaminophen overdosage can cause serious liver damage.,Do not take with other products containing acetaminophen or aspirin.,Avoid alcohol while taking this medication to reduce risk of liver toxicity and GI bleeding.,This product contains aspirin; do not give to children/teenagers with chickenpox or flu-like symptoms to avoid Reye's syndrome.,May cause drowsiness; do not drive or operate machinery until you know how you react.,Codeine is a narcotic pain reliever with abuse potential; use exactly as prescribed.,Seek medical attention if you experience signs of allergic reaction (rash, difficulty breathing) or bleeding (black/tarry stools, unusual bruising).

HY-PHEN

Take exactly as prescribed; do not increase dose or frequency without consulting your doctor.,Do not take other products containing acetaminophen (e.g., Tylenol, cold medicines) while using this medication to avoid liver damage.,Avoid alcohol completely while taking this drug; it increases the risk of liver damage and severe drowsiness.,Do not drive or operate heavy machinery until you know how this medication affects you; it may cause dizziness or drowsiness.,Store securely away from children and others; misuse can cause addiction, overdose, or death.,Do not stop taking suddenly after long-term use; your doctor will help you taper off to prevent withdrawal symptoms.

Safety Verification

Known Interactions

ACETAMINOPHEN, ASPIRIN, 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."

HY-PHEN Risks

No interactions on record

Compare Alternatives

Related Drug Comparisons

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

ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE vs ACETAMINOPHEN AND CODEINE PHOSPHATEOpioid Agonist
HY-PHEN vs ACETAMINOPHEN AND CODEINE PHOSPHATEOpioid Agonist
ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE vs ACETAMINOPHEN AND HYDROCODONE BITARTRATEOpioid Agonist
HY-PHEN vs ACETAMINOPHEN AND HYDROCODONE BITARTRATEOpioid Agonist
ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE vs ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDEOpioid Agonist-Antagonist
HY-PHEN vs ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDEOpioid Agonist-Antagonist
ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE vs ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATEOpioid Agonist
HY-PHEN vs ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATEOpioid Agonist
ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE vs ACETAMINOPHEN; OXYCODONE HYDROCHLORIDEOpioid Agonist
Clinical Q&A

Frequently Asked Questions

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

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

ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE is a Opioid Agonist that works by Acetaminophen: cyclooxygenase (COX) inhibitor, primarily central, analgesic and antipyretic. Aspirin: irreversible COX-1 and COX-2 inhibitor, analgesic, anti-inflammatory, antipyretic, antiplatelet. Codeine: prodrug converted to morphine; mu-opioid receptor agonist.. HY-PHEN is a Opioid Antitussive Combination that works by HY-PHEN is a combination of hydrocodone (a mu-opioid receptor agonist) and acetaminophen (an analgesic and antipyretic). Hydrocodone binds to mu-opioid receptors in the CNS, altering pain perception and emotional response to pain. Acetaminophen inhibits cyclooxygenase (COX) enzymes, particularly in the CNS, reducing prostaglandin synthesis.. They differ in pharmacokinetic profiles, FDA-approved indications, and side effect profiles.

2. Which is stronger: ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE or HY-PHEN?

Potency comparisons between ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE and HY-PHEN 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 CODEINE PHOSPHATE vs HY-PHEN?

The standard adult dose of ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE is: 1-2 tablets (each containing acetaminophen 300 mg, aspirin 300 mg, codeine phosphate 30 mg) orally every 4-6 hours as needed for pain; maximum 8 tablets/day.. The standard adult dose of HY-PHEN is: 1-2 tablets (acetaminophen 500 mg/hydrocodone 5-10 mg) orally every 4-6 hours as needed for pain; maximum 8 tablets per day.. Dosing should always be individualized based on indication, renal and hepatic function, age, and other patient factors.

4. Can you take ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE and HY-PHEN together?

No direct drug-drug interaction has been formally documented between ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE and HY-PHEN 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, ASPIRIN, AND CODEINE PHOSPHATE and HY-PHEN safe during pregnancy?

The maternal-fetal safety profiles differ. ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE is classified as Category D/X. Acetaminophen: Generally considered low risk; association with ASD and ADHD with prolonged use not fully established. Aspirin: First trimester: possible increased risk of gastrosch. HY-PHEN is classified as Category C. Pregnancy Category C. First trimester: No well-controlled studies; potential for fetal harm based on animal studies (cleft palate, skeletal anomalies). Second and third trimesters:. Always consult a maternal-fetal medicine specialist before taking either drug during pregnancy or lactation.