Drug reference

Paracetamol + Caffeine + Phenylephrine

NSAID · Cold and Flu Medication, Symptomatic Relief of Common Cold

Also known as Crocin Cold & Flu, Dolo Cold, Sumo Cold, FluCip, Sinarest, Vicks Action 500 Advance

NSAIDCold and Flu Medication, Symptomatic Relief of Common Cold

CDSCO approvedSchedule H

EXCRETION

—

not curated

INTERACTIONS

12 major

incl. contraindicated

PREGNANCY

Category C (Phenylephrine is Category C; Paracetamol is Category B; Caffeine is Category B or C depending on dose and source). Overall, the combination is generally considered Category C due to Phenylephrine. Use only if the potential benefit justifies the potential risk to the fetus.

FDA category + note

Top interactionssee all 12 →

SulfasalazineContraindicatedTextbookG&G 14e · p1112
AminoglycosideSevereTextbookKDT 7e · p746
AminoglycosidesSevereTextbookKDT 7e
AnticoagulantsSevereTextbookKDT 7e

Mechanism

Paracetamol exerts its analgesic and antipyretic effects primarily by inhibiting prostaglandin synthesis in the central nervous system. Caffeine acts as a central nervous system stimulant, enhancing the analgesic effect of paracetamol and counteracting the potential for sedation. Phenylephrine, an alpha-1 adrenergic agonist, causes vasoconstriction in the nasal mucosa, thereby reducing swelling and congestion. Combination rationale: This FDC combines a non-opioid analgesic and antipyretic (Paracetamol) with a central nervous system stimulant (Caffeine) to enhance the analgesic effect and counteract potential sedation, and a decongestant (Phenylephrine) to relieve nasal congestion. This combination provides comprehensive symptomatic relief for multiple common cold and flu symptoms such as fever, pain, and stuffy nose, improving patient convenience and compliance.

Indications

Symptomatic relief of nasal congestionFeverHeadacheBody acheSinusitis associated with common cold or fluAllergic rhinitis

Dosing

Adult: Oral: Typically 1 tablet containing Paracetamol 325-500 mg, Caffeine 25-30 mg, and Phenylephrine 5-10 mg, 3-4 times a day as needed. Do not exceed 4 doses in 24 hours.
Pediatric: Not recommended for children under 6 years. For children 6-12 years, consult a physician for age- and weight-appropriate dosing; specific pediatric formulations with lower strengths may be available. Generally, half the adult dose, not exceeding 4 doses in 24 hours.
Renal adjustment: Caution in severe renal impairment. Paracetamol clearance is reduced. Phenylephrine excretion is renal. Dose reduction may be required, particularly for paracetamol, based on creatinine clearance. Avoid if CrCl <10 mL/min for paracetamol components without close monitoring. Consult nephrologist for precise guidance in severe cases.…

Pharmacokinetics

Onset

Paracetamol: 30-60 minutes; Caffeine: 30-60 minutes; Phenylephrine: 15-20 minutes (oral)

Peak effect

Paracetamol: 1-2 hours; Caffeine: 30-120 minutes; Phenylephrine: 1-2 hours

Protein binding

Paracetamol: 10-25%; Caffeine: 15-35%; Phenylephrine: Low (<50%)

Contraindications

Hypersensitivity to any component
Severe hypertension
Coronary artery disease
Patients taking monoamine oxidase inhibitors (MAOIs) or within 14 days of discontinuing MAOI therapy
Hyperthyroidism
Severe hepatic or renal impairment
Angle-closure glaucoma
Prostatic hypertrophy
Diabetes mellitus (uncontrolled)

Side effects

Common

NauseaDizzinessInsomniaRestlessnessHeadachePalpitationsDry mouthMild gastrointestinal upsetNervousness

Serious

Severe allergic reactions (e.g., anaphylaxis, angioedema)
Hepatotoxicity (especially with paracetamol overdose)
Stevens-Johnson Syndrome (SJS)
Toxic Epidermal Necrolysis (TEN)
Severe hypertension
Tachycardia
Arrhythmias
Anxiety
Hallucinations
Acute renal failure (rare, in overdose or with pre-existing conditions)
Add "Reflex bradycardia"
Add "Atrophic rhinitis, Anosmia (with prolonged use)"
Add "Increased risk of severe hypertension, especially in patients with pre-existing hypertension or those concurrently taking MAO inhibitors."

Pregnancy & lactation

Pregnancy

Lactation

Paracetamol is generally considered safe during lactation. Caffeine is excreted into breast milk and can cause irritability or sleep disturbances in breastfed infants; use with caution. Phenylephrine can pass into breast milk and may potentially reduce milk supply, especially with prolonged use. It should be used with caution during breastfeeding, and infant monitoring for irritability or sleep issues is advised. Avoid prolonged or high-dose use.