Active Ingredient(In Each Tablet)
Chlorpheniramine Maleate 4 mg
Chlorpheniramine Maleate
FDA Label NDC 67046-097
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Contract Pharmacy Services-pa for the product Chlorpheniramine Maleate (NDC 67046-097). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient(in each tablet), purpose, uses, ask a doctor before use if you have,, ask a doctor or pharmacist before use if you, when using this product, if pregnant or breast feeding,, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
* Please review the disclaimer below.
