Source label information, not individualized medical advice. This record applies to the product and labeler shown below. Compare the exact formulation, strength and country with your package and the current source label.
This page contains 13 source sections for DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, oral route. Label set 4e578c7a-88d4-e4cd-e063-6394a90aac44, version 3.
Label records can cover multiple strengths or package sizes. A label listing does not by itself establish FDA approval or current market availability. Check the source and application history for this specific product.
Uses described in the label
USE(S) • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive • temporarily relieves: • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants • the intensity of coughing • the impulse to cough to help you get to sleep • nasal congestion due to a cold
DIRECTIONS • do not take more than 6 doses in any 24-hour period • measure only with dosing cup provided • do not use dosing cup with other products • dose as follows or as directed by a doctor • Adults and children 12 years and olde r: 20 ml in dosing cup provided every 4 hours . • Children under 12 years of age : Do not use
Warnings
WARNINGS .
Active ingredient
ACTIVE INGREDIENTS (in each 20 mL) Dextromethorphan HBr 20 mg Guaifenesin 400 mg Phenylephrine HCI 10 mg
Do not use
DO NOT USE • for children under 12 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.
Ask a doctor before use
ASK A DOCTOR BEFORE USE IF YOU HAVE • heart disease • high blood pressure • thyroid disease • diabetes • trouble urinating due to an enlarged prostate gland • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema • cough that occurs with too much phlegm (mucus)
While using this medicine
WHEN USING THIS PRODUCT • do not use more than directed
When to stop use and seek help
STOP USE AND ASK DOCTOR IF nervousness, dizziness or sleeplessness occur symptoms do not get better within 7 days or occur with fever cough comes back, or occurs with rash or persistent headache. These could be signs of a serious condition.
Pregnancy or breast feeding
PREGNANCY/BREASTFEEDING ask a health professional before use.
Child safety
KEEP OUT OF REACH OF CHILDREN In case of overdose, get medical help or contact a Poison Control Center right away.
Other safety information
OTHER INFORMATION • each 20 ml contains : sodium 20 mg • store between 15-30ºC (59-86ºF) • do not refrigerate • dosing cup provided
The text is extracted from a US structured product label. Tables are represented as text where supplied; formatting and illustrations may be lost. A missing section does not mean a risk is absent. This reference has not been independently reviewed by a clinician and is not a live safety-alert service.