CHLORPHENIRAMINE MALEATE- chlorpheniramine maleate tablet 
DIRECT RX

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.

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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

DOSAGE & ADMINISTRATION SECTION

INFORMATION FOR PATIENTS SECTION

INACTIVE INGREDIENT SECTION

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

image description

CHLORPHENIRAMINE MALEATE 
chlorpheniramine maleate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61919-402(NDC:0904-0012)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE4 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
Product Characteristics
ColoryellowScore2 pieces
ShapeROUNDSize8mm
FlavorImprint Code 44;194
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61919-402-711 in 1 CARTON; Type 0: Not a Combination Product01/01/2014
2NDC:61919-402-3030 in 1 BOTTLE; Type 0: Not a Combination Product01/01/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/01/2014
Labeler - DIRECT RX (079254320)
Establishment
NameAddressID/FEIBusiness Operations
DIRECT RX079254320relabel(61919-402) , repack(61919-402)

Revised: 12/2015
Document Id: 2badb011-7f09-440c-9aea-59ad6004cfe4
Set id: 4c59bf7c-eb93-4792-9326-0076e7c55c39
Version: 3
Effective Time: 20151208
 
DIRECT RX