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 16 source sections for CHLORPHENIRAMINE MALEATE, DEXTROMETRORPHAN HBR, oral route. Label set 035c5e2a-04e3-490b-8f1a-233a5cb6eadb, version 6.
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 due to minor throat and bronchial irritation as may occur with a cold ▪ temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: ▪ runny nose ▪ sneezing ▪ itchy, watery eyes ▪ itching of the nose or throat
Purpose
PURPOSES Antihistamine Cough suppressant Uses ▪ temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold ▪ temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: ▪ runny nose ▪ sneezing ▪ itchy, watery eyes ▪ itching of the nose or throat
Dosage and administration — label text
Directions ▪ measure only with dosing cup provided ▪ keep dosing cup with product ▪ mL = milliliter ▪ do not take more than 4 doses in any 24-hour period age dose Children under 6 years do not use children 6 to under 12 years 10 mL every 6 hours adults and children 12 years and older 20 mL every 6 hours Other information ▪ each 10 mL contains: sodium 7 mg ▪ store at room temperature, Do not refrigerate.
Table text from source:
| age | dose
| Children under 6 years | do not use
| children 6 to under 12 years | 10 mL every 6 hours
| adults and children 12 years and older | 20 mL every 6 hours
Warnings
WARNINGS Do not use • to sedate a child or to make a child sleepy • 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 if you have • trouble urinating due to an enlarged prostate gland • glaucoma • a cough that occurs with too much phlegm (mucus) • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis 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 ▪ marked drowsiness may occur ▪ avoid alcoholic drinks ▪ 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 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 reach of children. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Directions ▪ measure only with dosing cup provided ▪ keep dosing cup with product ▪ mL = milliliter ▪ do not take more than 4 doses in any 24-hour period age dose Children under 6 years do not use children 6 to under 12 years 10 mL every 6 hours adults and children 12 years and older 20 mL every 6 hours Other information ▪ each 10 mL contains: sodium 7 mg ▪ store at room temperature, Do not refrigerate.
Table text from source:
| age | dose
| Children under 6 years | do not use
| children 6 to under 12 years | 10 mL every 6 hours
| adults and children 12 years and older | 20 mL every 6 hours
Unclassified section
DRUG FACTS
Active ingredient
ACTIVE INGREDIENTS (in each 10 mL) Chlorpheniramine maleate, USP 2 mg Dextromethorphan HBr, USP 15 mg
Do not use
Do not use • to sedate a child or to make a child sleepy • 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 • trouble urinating due to an enlarged prostate gland • glaucoma • a cough that occurs with too much phlegm (mucus) • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis 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 ▪ marked drowsiness may occur ▪ avoid alcoholic drinks ▪ 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 more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
Pregnancy or breast feeding
If pregnant or breast-feeding, 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 at 1-800-222-1222.
Other safety information
Other information ▪ each 10 mL contains: sodium 7 mg ▪ store at room temperature, Do not refrigerate.
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.