Stearns Cough Syrup 100mg / 5ml Syrup
PDF Leaflet Revision Date: 31 March 2006
Clinical Summary
Quick overview from the medicine insert
Indication
Alleviation of cough associated with viscid/tenacious phlegm.
Dosage (summary)
Adults: 200-400 mg (10-20 ml) every 4 hours; max 2400 mg (120 ml) in 24 hours.
Special Populations
- Children under 2 years
Pregnancy & Breastfeeding
Safety in pregnancy and lactation not established; unknown if distributed in breast milk.
Key Drug Interactions
- Interferes with urine tests for 5-HIAA and VMA
Contraindications
- Hypersensitivity to ingredients
- Porphyria
Common side effects
- Nausea
- Vomiting
- Diarrhoea
- Dizziness
- Headache
Counselling Points
- Do not exceed recommended dosage
- Keep out of reach of children
Serious warnings
- Persistent cough may indicate serious condition
- Consult doctor if cough persists over one week
Important Disclaimer
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Clinical Particulars
Section 4 of the official insert — extracted exactly as issued, no alterations
4.1 Therapeutic indications
Alleviation of cough associated with viscid/tenacious phlegm.
4.2 Posology and method of administration
Adults and children 12 years and over: Oral dosage is 200 mg to 400 mg (10 ml to 20 ml) every 4 hours. Do not exceed 2 400 mg (120 ml) in 24 hours.
Children 6 to under 12 years: Oral dosage is 100 mg to 200 mg (5 ml to 10 ml) every 4 hours. Do not exceed 1 200 mg (60 ml) in 24 hours.
Children 2 to under 6 years: Oral dosage is 50 to 100 mg (2,5 ml to 5 ml) every 4 hours. Do not exceed 600 mg (30 ml) in 24 hours, or as directed by a doctor.
4.3 Contraindications
Hypersensitivity to any of the ingredients. Porphyria (see u2018WARNINGS AND SPECIAL PRECAUTIONSu2019).
4.4 Special warnings and precautions for use
A persistent cough may be a sign of a serious condition. If cough persists for more than one week, tends to recur or is accompanied by high fever, skin rash, sore throat or persistent headache, consult a doctor.
STEARNS should not be given to children under 2 years unless recommended by a doctor.
Porphyria: Safety has not been established.
4.5 Interactions with other medicines
Guaiphenesin interferes with urine tests for 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).
4.6 Fertility, pregnancy and lactation
Pregnancy: The safety of this medicine in pregnancy and lactation has not been established.
Lactation: It is not known whether guaiphenesin is distributed into breast milk. However, problems in humans have not been documented.
4.8 Undesirable effects
Gastrointestinal disorders: Less frequent: nausea, vomiting, diarrhoea, stomach pain and gastrointestinal discomfort.
Nervous system disorders: Less frequent: dizziness and headache.
Skin and subcutaneous tissue disorders: Less frequent: skin rash and urticaria.
4.9 Overdose
Signs and symptoms of overdosage: Very large doses can cause gastrointestinal discomfort, nausea and vomiting.
Treatment of overdose: Treatment is symptomatic and supportive.
