Dosage form: liquid
Ingredients: Codeine phosphate 10mg in 5mL, Guaifenesin 100mg in 5mL, Pseudoephedrine Hydrochloride 30mg in 5mL
Labeler: Virtus Pharmaceuticals
NDC Code: 69543-253
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
|Active ingredients (in each 5 mL = 1 tsp)||Purpose|
|Codeine phosphate, USP 10 mg||Cough Suppressant|
|Guaifenesin, USP 100 mg||Expectorant|
|Pseudoephedrine HCl, USP 30 mg||Nasal Decongestant|
- 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
Ask your doctor before use if you have
- heart disease
- high blood pressure
- thyroid disease
- 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
- 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
- do not use more than directed
- may cause drowsiness
- constipation may occur or be aggravated
- 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.
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.
- do not exceed 4 doses in any 24 hour period.
|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.|
|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.|
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.
Alcohol, caramel flavor, cherry flavor, citric acid, FD&C red #40, glycerin, menthol flavor, potassium citrate, propylene glycol, purified water, sodium benzoate, sodium saccharin, sorbitol 70% solution.
SUGAR FREE • 2.1% (v/v) ALCOHOL
Each 5 mL (1 teaspoonful) contains:
Codeine phosphate, USP 10 mg
Guaifenesin, USP 100 mg
Pseudoephedrine HCl, USP 30 mg
(WARNING: May be habit-forming)
Tamper evident by foil
seal under cap.
Do not use if foil seal is
broken or missing.
16 fl. oz. (473 mL)
codeine phosphate, guaifenesin, and pseudoephedrine hydrochloride liquid
|Labeler - Virtus Pharmaceuticals (079659493)|
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.