CONTRA SG CAP 30/CAP

Indications

Approved Uses

Symptomatic relief of cough associated with colds/upper respiratory tract infections, including cough with chest congestion (productive cough) where an expectorant is needed.

Dosage & Administration

Dosing by Condition

Adults and adolescents ≥12 years: 1 softgel capsule (15/200 mg) every 4 hours as needed; do not exceed 6 capsules in 24 hours unless otherwise directed by a prescriber.

Initial Dose

1 capsule (Dextromethorphan 15mg / Guaifenesin 200mg) every 4 hours

Maintenance Dose

One 15mg/200mg capsule every 4-6 hours.

Maximum Dose

Do not exceed 60 mL daily for common OTC syrup (equivalent to dextromethorphan 120 mg/day, guaifenesin 2400 mg/day); capsule dosing not specified

Children's Dosage

Not recommended for children under 12 years of age unless directed by a doctor.

Dose Adjustment Notes

No specific dose-adjustment recommendations are established; use caution in hepatic impairment (and in CYP2D6 poor metabolizers or with strong CYP2D6 inhibitors) due to increased dextromethorphan exposure.

How to Take

Swallow the softgel capsule whole with a full glass of water; may be taken with or without food. Maintain adequate fluid intake to support guaifenesin’s expectorant effect.

Side Effects

Common Side Effects

Nausea, vomiting, dizziness, drowsiness, headache, gastrointestinal upset, stomach pain

Side Effect Frequency

Common: dizziness, drowsiness/somnolence, nausea, vomiting, gastrointestinal upset (e.g., abdominal pain); Uncommon/Rare: rash/urticaria or other hypersensitivity reactions; Very rare/serious: serotonin syndrome (with serotonergic interacting drugs) and hallucinations/CNS toxicity mainly with overdose/abuse.

Safety & Warnings

Contraindications

Contraindicated with concomitant MAOI use or within 14 days of stopping an MAOI; contraindicated in patients with known hypersensitivity to dextromethorphan or guaifenesin (or excipients).

Warnings & Precautions

Avoid use with/within 14 days of MAOIs; caution with other serotonergic drugs (serotonin syndrome risk) and with CYP2D6 inhibitors; do not use for chronic cough (e.g., smoking/asthma/emphysema) or cough with excessive sputum unless medically evaluated; do not exceed recommended dose and stop/seek care if cough persists >7 days or is accompanied by fever/rash/persistent headache; caution in hepatic impairment and with alcohol/CNS depressants; misuse/abuse potential exists with dextromethorphan at high doses.

Age Restriction

Not recommended for children <4 years. FDA recommends against use in pediatric patients; American Academy of Pediatrics recommends against use in children <4 years, though some studies suggest use in children ≥2 years with accurate dosing.

Driving Warning

May Cause Drowsiness

Drug Interactions

Drug Interactions

Major: MAOIs (contraindicated) and other serotonergic drugs (e.g., SSRIs/SNRIs/TCAs/linezolid/triptans) due to serotonin syndrome risk; CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine, bupropion, amiodarone) can increase dextromethorphan exposure; additive CNS depression with alcohol/sedatives may occur.

Interaction Severity

MAJOR/Contraindicated: MAO inhibitors (and within 14 days of stopping) due to serotonin syndrome/hypertensive reactions. MODERATE: other serotonergic drugs (SSRIs/SNRIs/TCAs/triptans/linezolid, etc.)-serotonin syndrome risk; strong CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine, bupropion) and CYP3A4 inhibitors-↑ dextromethorphan exposure/toxicity; CNS depressants including alcohol, opioids, benzodiazepines-additive sedation/impairment.

Alcohol Interaction

Avoid

Special Populations

Children

Not recommended for children under 12 years of age unless directed by a doctor.

Elderly

Use with caution; start at lower end of dosing range due to increased sensitivity to CNS effects and potential for drug accumulation.

Kidney Impairment

No specific dose adjustment provided; use with caution in significant renal impairment.

Liver Impairment

No specific manufacturer dose adjustment; use with caution in hepatic impairment (especially moderate-severe) and monitor for CNS/serotonergic toxicity.

Storage & Patient Advice

Stopping the Medicine

May be stopped at any time; no taper is required when used short-term for acute cough.

Overdose

Overdose may cause nausea/vomiting, dizziness, marked drowsiness, ataxia, agitation/confusion, hallucinations, hypertension/tachycardia, seizures, respiratory depression/coma; serotonin syndrome is possible with dextromethorphan-seek urgent care/poison center, provide supportive care, consider activated charcoal if early, and naloxone may be considered for significant CNS/respiratory depression.

Patient Counseling

Swallow each softgel with a full glass of water and keep well-hydrated; do not exceed 6 capsules/24 hours unless directed. Avoid use with MAOIs or within 14 days of stopping an MAOI; use caution with other serotonergic medicines and avoid alcohol/CNS depressants. May cause dizziness/drowsiness-avoid driving until effects are known. Seek medical advice if cough lasts >7 days, recurs, worsens, or is accompanied by fever/rash/persistent headache, or if chronic cough (e.g., asthma/COPD/smoking) is present.

Monitoring Requirements

No routine monitoring required for short-term use.

Pharmacology

Mechanism of Action

Dextromethorphan suppresses the cough reflex via central action on the medullary cough center (including sigma-1 activity and NMDA antagonism). Guaifenesin increases respiratory tract fluid/secretions, reducing mucus viscosity and aiding expectoration.

Metabolism

Dextromethorphan: extensive hepatic metabolism mainly by CYP2D6 (to dextrorphan) and also CYP3A4. Guaifenesin: hepatic metabolism (oxidation/demethylation) to inactive metabolites.

Product Information

Available Dosage Forms

Softgel capsule (oral).

Composition per Dose

Each softgel capsule: Dextromethorphan HBr 15mg + Guaifenesin 200mg

Generic Availability

Yes

OTC Alternatives

This specific product is prescription-only per SFDA; however, OTC alternatives may exist in some markets as single-ingredient dextromethorphan or guaifenesin products (availability depends on local regulation).

Symptom Target

Multi-symptom

Sedating

Yes

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