Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 2c6f254b-0453-4c79-8b3e-8373335b474e
Route
ORAL
Published
Effective Date 2012-09-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chlorpheniramine (4 mg)
Inactive Ingredients
Microcrystalline Wax Anhydrous Lactose Sodium Starch Glycolate Type A Potato Starch, Corn Crospovidone Silicon Dioxide Stearic Acid Hypromelloses Fd&c Red No. 40 Fd&c Yellow No. 5 Titanium Dioxide Polyethylene Glycols Ethanethiol

Identifiers & Packaging

Pill Appearance
Imprint: BT Shape: round Color: blue Size: 9 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2011-08-18

Description

Chlorpheniramine Maleate 4mg

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Chlorpheniramine Maleate 4mg

Uses
  • temporarily relieves minor symptoms due to hay fever or other upper respiratory allergies such as:
    • sneezing
    • runny nose
    • itchy, watery eyes
    • itchy throat

Warnings


Ask a doctor before use it you have

  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • difficulty in urinating due to enlargement of the prostate gland
  • asthma, shortness of breath



Directions
  • Adults and children 12 years and over: Take one (1) tablet every 4 to 6 hours. Do not exceed 6 tablets in 24 hours.
  • Children 12 years and under: Consult a physician before use



Package Label

Other Information
  • store at 20° to 25°C (68°-67°F)
  • protect from excessive moisture

  • Do not exceed recommended dose

Inactive Ingredients

microcrystalline cellulose, lactose anhydrous, sodium starch glycolate, corn starch glycolate, crospovidone, silicon dioxide, stearic acid, hypromellose, FDC red no.40, FDC yellow no.5, titanium dioxide, polyethyleneglycol, ethanol

When Using This Product
  • you may get drowsy

  • 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

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

In case of accidental overdose get medical help or contact a Poison Control Center right away.

Active Ingredient (in Each Tablet)

Chlorpheniramine Maleate 4mg

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers


Structured Label Content

Uses
  • temporarily relieves minor symptoms due to hay fever or other upper respiratory allergies such as:
    • sneezing
    • runny nose
    • itchy, watery eyes
    • itchy throat

Purpose

Antihistamine

Warnings


Ask a doctor before use it you have

  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • difficulty in urinating due to enlargement of the prostate gland
  • asthma, shortness of breath



Directions
  • Adults and children 12 years and over: Take one (1) tablet every 4 to 6 hours. Do not exceed 6 tablets in 24 hours.
  • Children 12 years and under: Consult a physician before use



Package Label (Package label)

Other Information (Other information)
  • store at 20° to 25°C (68°-67°F)
  • protect from excessive moisture

  • Do not exceed recommended dose

Inactive Ingredients (Inactive ingredients)

microcrystalline cellulose, lactose anhydrous, sodium starch glycolate, corn starch glycolate, crospovidone, silicon dioxide, stearic acid, hypromellose, FDC red no.40, FDC yellow no.5, titanium dioxide, polyethyleneglycol, ethanol

When Using This Product (When using this product)
  • you may get drowsy

  • 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

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of accidental overdose get medical help or contact a Poison Control Center right away.

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Chlorpheniramine Maleate 4mg

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)