CHLORPHENIRAMINE MALEATE tablet

CHLORPHENIRAMINE MALEATE by

Drug Labeling and Warnings

CHLORPHENIRAMINE MALEATE by is a Otc medication manufactured, distributed, or labeled by DIRECT RX. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 age		do 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

INGREDIENTS AND APPEARANCE

CHLORPHENIRAMINE MALEATE 
chlorpheniramine maleate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61919-402(NDC:0904-0012)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	4 mg

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

Product Characteristics
Color	yellow	Score	2 pieces
Shape	ROUND	Size	8mm
Flavor		Imprint Code	44;194
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61919-402-71	1 in 1 CARTON; Type 0: Not a Combination Product	01/01/2014
2	NDC: 61919-402-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	01/01/2014

Labeler - DIRECT RX (079254320)

Establishment
Name	Address	ID/FEI	Business Operations
DIRECT RX		079254320	relabel(61919-402) , repack(61919-402)