FDA Label for Chlorpheniramine Maleate
View Indications, Usage & Precautions
Chlorpheniramine Maleate Product Label
The following document was submitted to the FDA by the labeler of this product Contract Pharmacy Services-pa. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient(In Each Tablet)
Chlorpheniramine Maleate 4 mg
Purpose
Antihistamine
Uses
Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- itchy nose or throat
- itchy watery eyes
- sneezing
Ask A Doctor Before Use If You Have,
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- trouble urinating due to enlarged prostate gland
Ask A Doctor Or Pharmacist Before Use If You
are taking sedatives or tranquilizers
When Using This Product
- excitability may occur, especially in children
- drowsiness may occur
- avoid alcoholic beverages
- alcohol, sedatives and tranquilizers may increase drowsiness
- use caution when driving a motor vehicle or operating machinery
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.
Directions
| adults and children 12 years of age and older
| one tablet 4 to 6 hours, not to exceed 6 tablets in 24 hours
|
| children 6 to under 12 years of age
| 1/2 tablet every 4 to 6 hours, not to exceed 3 whole tablets in 24 hours
|
| children under 6 years of age
| consult a physician
|
Other Information
- Tamper Evident: Do not Use If Safety Seal Under Cap Is Broken Or Missing
- store at controlled room temperature 15 o-25 oC (59 o-77 oF)
- protect from excessive moisture
Questions:
To Report Adverse Drug Events Call 800-687-0176.
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