Chlorpheniramine Maleate
FDA Label NDC 66424-034

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sda Laboratories, Inc. for the product Chlorpheniramine Maleate (NDC 66424-034). 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

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 15o-25oC (59o-77oF)
  • protect from excessive moisture

Questions:

To Report Adverse Drug Events Call 800-687-0176.

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