CHILDREN'S ELIXSURE
Clinical safety rating: caution
Comprehensive clinical and safety monograph for CHILDREN'S ELIXSURE (CHILDREN'S ELIXSURE).
Acetaminophen: weakly inhibits cyclooxygenase (COX) in central nervous system, reduces prostaglandin synthesis, elevates pain threshold, and acts on hypothalamic heat-regulating center to lower body temperature. Chlorpheniramine: first-generation antihistamine; competitively antagonizes histamine at H1 receptors, reducing allergic symptoms. Dextromethorphan: noncompetitive NMDA receptor antagonist and sigma-1 agonist; suppresses cough by elevating threshold in medullary cough center. Pseudoephedrine: indirectly acting sympathomimetic; releases norepinephrine from presynaptic terminals, causing vasoconstriction and nasal decongestion.
| Metabolism | Acetaminophen: hepatically metabolized via glucuronidation and sulfation; minor CYP2E1, CYP3A4, and CYP1A2. Chlorpheniramine: extensively hepatic via CYP450; major CYP2D6. Dextromethorphan: hepatic CYP2D6 to active metabolite dextrorphan; also CYP3A. Pseudoephedrine: partially hepatic N-demethylation; majority excreted unchanged in urine. |
| Excretion | Renal elimination: ~90% as unchanged drug and active metabolite paracetamol glucuronide/sulfate conjugates; biliary/fecal: <5%. |
| Half-life | Terminal half-life: 4–6 hours in children with normal hepatic function; prolonged to >8 hours in hepatic impairment or overdose. |
| Protein binding | 10–25% bound to plasma proteins (albumin); minimal binding at therapeutic concentrations. |
| Volume of Distribution | 0.9–1.0 L/kg (in children); moderately distributed throughout body fluids. |
| Bioavailability | Oral: 85–95% (first-pass metabolism ~10–15%); rectal: 70–80%. |
| Onset of Action | Oral: 30–60 minutes; peak effect at 1–2 hours. |
| Duration of Action | Analgesic and antipyretic effects: 4–6 hours; clinical dosing interval every 4–6 hours. |
| Molecular Weight | 151.16 |
No established adult dose; product is specifically indicated for pediatric use only. Not recommended for adults.
| Dosage form | SUSPENSION |
| Renal impairment | No data available for adult renal impairment; use is contraindicated in renal impairment due to acetaminophen and chlorpheniramine components. |
| Liver impairment | Contraindicated in severe hepatic impairment (Child-Pugh class C). For mild-to-moderate impairment (Child-Pugh A/B), use with caution and consider dose reduction; specific recommendations not established. |
| Pediatric use | Weight-based dosing per acetaminophen component: 10-15 mg/kg/dose every 4-6 hours as needed, not exceeding 5 doses (or 75 mg/kg) per day. Age-based dosing: Children 2-3 years (24-35 lbs): 5 mL (160 mg acetaminophen) every 4-6 hours; 4-5 years (36-47 lbs): 7.5 mL; 6-8 years (48-59 lbs): 10 mL; 9-10 years (60-71 lbs): 12.5 mL; 11 years (72-95 lbs): 15 mL. Do not exceed adult dose. |
| Geriatric use | No specific geriatric dosing; not indicated for use in elderly patients. Elderly may be more sensitive to anticholinergic effects of chlorpheniramine (confusion, sedation). |
| 1st trimester | Avoid due to insufficient safety data and potential teratogenic effects; case reports of fetal harm with acetaminophen overdose. |
| 2nd trimester | Use only if clearly needed; limited data suggest low risk at therapeutic doses. |
| 3rd trimester | Avoid due to possible adverse effects on fetal kidney development and cardiovascular system. |
Clinical note
Comprehensive clinical and safety monograph for CHILDREN'S ELIXSURE (CHILDREN'S ELIXSURE).
| Placental transfer | Acetaminophen crosses the placenta readily; fetal concentrations similar to maternal. |
| Breastfeeding | Acetaminophen is excreted into breast milk in low concentrations (less than 2% of maternal dose). Considered compatible with breastfeeding; however, monitor infant for rash or unusual symptoms. |
■ FDA Black Box Warning
None
| Serious Effects |
Hypersensitivity to acetaminophenSevere hepatic impairmentUse of other acetaminophen-containing products due to risk of overdose
| Precautions | Acetaminophen may cause severe hepatotoxicity in overdose; do not exceed daily maximum. Do not combine with other acetaminophen-containing products. Pseudoephedrine: caution in hypertension, hyperthyroidism, diabetes, and heart disease due to vasopressor effects. Dextromethorphan: avoid with MAOIs; caution in chronic cough. Chlorpheniramine: may cause drowsiness; avoid alcohol. Not for use under 2 years of age. |
| Food/Dietary | Avoid alcohol consumption due to increased risk of liver toxicity from acetaminophen and additive CNS depression. No significant food interactions; can be taken with or without food. |
Loading safety data…
| Lactation Rating |
| L1 – Safe |
| Teratogenic Risk | CHILDREN'S ELIXSURE is a combination product containing acetaminophen, dextromethorphan, and pseudoephedrine. Acetaminophen: No increased risk of major malformations from therapeutic doses in all trimesters. Dextromethorphan: Limited human data; animal studies show no teratogenicity at therapeutic doses. Pseudoephedrine: Contraindicated in first trimester due to possible association with gastroschisis; second and third trimester use may reduce uterine blood flow. |
| Fetal Monitoring | Monitor maternal blood pressure with pseudoephedrine (risk of hypertension). Fetal ultrasound for potential gastroschisis if first-trimester exposure. Assess neonatal withdrawal/toxicity if chronic use near term. |
| Fertility Effects | Acetaminophen: May impair fertility in females when used chronically (prostaglandin inhibition). Dextromethorphan: No known effect. Pseudoephedrine: No known direct effect on fertility. |
| Clinical Pearls | CHILDREN'S ELIXSURE typically contains a combination of acetaminophen (pain/fever), chlorpheniramine (antihistamine), and dextromethorphan (antitussive). Avoid exceeding maximum daily acetaminophen dose (75 mg/kg/day in children, up to 4 g in adults). Monitor for CNS depression when combined with other sedatives. Use with caution in children with hepatic impairment, G6PD deficiency, or respiratory conditions like asthma. |
| Patient Advice | Do not exceed recommended dose; overdose of acetaminophen can cause liver damage. · May cause drowsiness; avoid activities requiring alertness until effects known. · Do not use with other products containing acetaminophen or similar ingredients. · Shake well before use; use only with dosing cup provided. · Seek medical help if symptoms persist beyond 5 days or fever >3 days. |