Active ingredientCODEINE PHOSPHATE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE
Label structure12 sections
Indications and uses
▪ temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold ▪ temporarily relieves nasal congestion due to the common cold ▪ temporarily restores freer breathing through the nose ▪ helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive ▪ calms the cough control center and relieves coughing
Dosage and administration
▪ do not exceed 4 doses in any 24 hour period. Adults and children 12 years of age and over: 2 tsp (10 mL) every 4 hours, or as directed by a doctor. Children 6 to under 12 years of age: 1 tsp (5 mL) every 4 hours, or as directed by a doctor. Children under 6 years of age: Consult a doctor. Attention: A special measuring device should be used to give an accurate dose of this product to children under...
temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
temporarily relieves nasal congestion due to the common cold
temporarily restores freer breathing through the nose
helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
calms the cough control center and relieves coughing
Warnings
WARNINGS SECTION
Ask your doctor before use if you have
heart disease
high blood pressure
thyroid disease
diabetes
trouble urinating due to enlarged prostate gland
cough that occurs with excessive phlegm (mucus)
cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Do not use
SPL UNCLASSIFIED SECTION
in a child under 2 years of age
if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
if you or your child has a chronic pulmonary disease or shortness of breath
if your child is taking other drugs, unless directed by a doctor
When using this product
SPL UNCLASSIFIED SECTION
do not use more than directed
may cause drowsiness
constipation may occur or be aggravated
Stop use and ask a doctor if
SPL UNCLASSIFIED SECTION
you get nervous, dizzy, or have trouble sleeping
cough lasts more than 7 days, comes back or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
If pregnant or breast-feeding, ask a health professional before use.
Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
DOSAGE & ADMINISTRATION SECTION
do not exceed 4 doses in any 24 hour period.
Adults and children 12 years of age and over:
2 tsp (10 mL) every 4 hours, or as directed by a doctor.
Children 6 to under 12 years of age:
1 tsp (5 mL) every 4 hours, or as directed by a doctor.
Children under 6 years of age:
Consult a doctor.
Attention: A special measuring device should be used to give an accurate dose of this product to children under 6 years of age. Giving a higher dose than recommended by a doctor could result in serious side effects for your child.
Other information
SPL UNCLASSIFIED SECTION
Each tsp (5 mL) contains 3 mg sodium. Store at controlled room temperature 15°-30°C (59°-86°F). You may report side effects by calling 1-888-848-3593 or FDA at 1-800-FDA-1088.
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.