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 15 source sections for BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, oral route. Label set 24758ab0-ba08-4b4a-9861-449612bdb89c, 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
Uses • temporarily relieves: • cough • runny nose • sneezing • itching of the nose or throat • itchy, watery eyes due to hay fever (or other upper respiratory allergies) • temporarily alleviates the intensity of coughing
Purpose
Purposes Antihistamine Cough suppressant
Dosage and administration — label text
Directions • do not take more than 6 doses in any 24-hour period • measure only with dosage cup provided • keep dosage cup with product • mL = milliliter age dose adults and children 12 years over 20 mL every 4 hours children 6 to under 12 years 10 mL every 4 hours children under 6 years do not use
Table text from source:
| age | dose
| adults and children 12 years over | 20 mL every 4 hours
| children 6 to under 12 years | 10 mL every 4 hours
| children under 6 years | do not use
Warnings
Warnings Do not use • 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. • to make a child sleepy Ask a doctor before use if you have • trouble urinating due to an enlarged prostate gland • glaucoma • cough that occurs with too much phlegm (mucus) • a breathing problem such as emphysema or chronic bronchitis • cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product • do not use more than directed • may cause marked drowsiness • avoid alcoholic beverages • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery • excitability may occur, especially in children Stop use and ask a doctor if cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition. If pregnant or breast-feeding, Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Active ingredient
Active ingredients (in each 10 mL) Brompheniramine maleate 2 mg Dextromethorphan HBr 10 mg
Do not use
Do not use • 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. • to make a child sleepy
Ask a doctor before use
Ask a doctor before use if you have • trouble urinating due to an enlarged prostate gland • glaucoma • cough that occurs with too much phlegm (mucus) • a breathing problem such as emphysema or chronic bronchitis • cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema
Ask a doctor or pharmacist
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers
While using this medicine
When using this product • do not use more than directed • may cause marked drowsiness • avoid alcoholic beverages • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery • excitability may occur, especially in children
When to stop use and seek help
Stop use and ask a doctor if cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
Pregnancy or breast feeding
If pregnant or breast-feeding,
Child safety
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Other safety information
Other information • each 10 mL contains: sodium 4 mg • store at 20°-25°C (68°-77°F)
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.