Dosage form: liquid
Ingredients: Chlophedianol Hydrochloride 12.5mg in 5mL, Guaifenesin 100mg in 5mL, Phenylephrine Hydrochloride 5mg in 5mL
Labeler: Portal Pharmaceutical
NDC Code: 49963-630
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.
(in each 5 mL teaspoonful)
Chlophedianol Hydrochloride 12.5 mg
Guaifenesin 100 mg
Phenylephrine Hydrochloride 5 mg
- cough due to minor throat and bronchial irritation
- helps loosen phelgm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
- nasal congestion
- reduces swelling of the nasal passages
- 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
- a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
- a cough that occurs with too much phlegm (mucus)
- heart disease
- high blood pressure
- thyroid disease
- trouble urinating due to an enlarged prostate gland
- nervousness, dizziness, or sleeplessness occur
- cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. These could be signs of a serious condition.
- new symptoms occur
|Adults and children 12 years of age and over:||2 teaspoonfuls every 6 to 8 hours, not to exceed 8 teaspoonfuls in a 24 hour period
|Children 6 to under 12 years of age:||1 teaspoonful every 6 to 8 hours, not to exceed 4 teaspoonfuls in a 24 hour period
|Children under 6 years of age||Consult a doctor
Serious side effects associated with this product may be reported to this number.
Principal display panel and side panel for 118 mL label:
Each teaspoonful (5 mL) for oral administration contains:
Chlophedianol HCl.....................................12.5 mg
Phenylephrine HCl.........................................5 mg
Cough Suppressant/Expectorant/Nasal Decongestant
Alcohol Free/Dye Free/Gluten Free/Sugar Free
4 fl oz (118 mL)
Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.
Supplied in a tight, light-resistant container with a child-resistant cap.
See package insert for full prescribing information.
Mayaguez, PR 00680 Rev. 10/09
chlophedianol hydrochloride, guaifenesin, phenylephrine hydrochloride liquid
|Labeler - Portal Pharmaceutical (831005199)|
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.