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CHLORPHENIRAMINE MALEATE by DIRECT RX

Medically reviewed on December 8, 2017

Dosage form: tablet
Ingredients: CHLORPHENIRAMINE MALEATE 4mg
Labeler: DIRECT RX
NDC Code: 61919-402

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

CHLORPHENIRAMINE MALEATE

OTC - ACTIVE INGREDIENT SECTION

Chlorpheniramine maleate 4 mg

OTC - PURPOSE SECTION

Antihistamine

INDICATIONS & USAGE SECTION

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
runny nose
itchy, watery eyes
sneezing
itching of the nose or throat

OTC - KEEP OUT OF REACH OF CHILDREN SECTION
  • Do not use

    to make a child sleepy.

    Ask a doctor before use if you have
    • a breathing problem such as emphysema or chronic bronchitis  
    • glaucoma
    • trouble urinating due to an enlarged prostate gland

    Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers.

    When using this product
    • drowsiness may occur
    • avoid alcoholic beverages
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • use caution 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 overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

´╗┐DOSAGE & ADMINISTRATION SECTION´╗┐
  • adults and children
    12 years  of age
    and over
    1 tablet every 4 to 6
    hours. Do not take more than 6 tablets in 24 hours.
    children 6 to under 12 years of  age

    1/2 tablet (break tablet in half) every 4 to 6 hours.
    Do not exceed 3 whole tablets in 24 hours.
    children under 6 years of agedo not use this product in children under 6 years of age

INFORMATION FOR PATIENTS SECTION
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • protect from excessive moisture
  • see end flap for expiration date and lot number

INACTIVE INGREDIENT SECTION
  • corn starch, D&C yellow #10 aluminum lake, lactose anhydrous, magnesium stearate, microcrystalline cellulose

OTC - QUESTIONS SECTION

(800) 616-2471

WARNINGS SECTION


Do not use

to make a child sleepy.

Ask a doctor before use if you have
a breathing problem such as emphysema or chronic bronchitis
glaucoma
trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product
drowsiness may occur
avoid alcoholic beverages
alcohol, sedatives, and tranquilizers may increase drowsiness
use caution 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 overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CHLORPHENIRAMINE MALEATE 
chlorpheniramine maleate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61919-402(NDC:0904-0012)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE4 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE 
D&C YELLOW NO. 10 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
Product Characteristics
ColoryellowScore2 pieces
ShapeROUNDSize8mm
FlavorImprint Code44;194
Contains    
Packaging
#Item CodePackage Description
1NDC:61919-402-711 TABLET in 1 CARTON
2NDC:61919-402-3030 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/01/2014
Labeler - DIRECT RX (079254320)
Establishment
NameAddressID/FEIOperations
DIRECT RX079254320relabel(61919-402), repack(61919-402)

 
DIRECT RX

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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