CHLORPHENIRAMINE MALEATE tablet

Chlorpheniramine Maleate by

Drug Labeling and Warnings

Chlorpheniramine Maleate by is a Otc medication manufactured, distributed, or labeled by PD-Rx Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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, watery eyes
• sneezing
• itching of the nose or throat

Warnings

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
• difficulty in urination due to enlargement of the prostate gland
  
• glaucoma

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 right away (800-222-1222) right away.

Directions

• take every 4 to 6 hours, or as directed by a doctor

• adults and children 12 years and over: 1 tablet. Do not exceed 6 tablets in 24 hours.
• children 6 to under 12 years: 1/2 tablet (break tablet in half). Do not exceed 3 whole tablets in 24 hours.
• children under 6 years: do not use

Other information

• store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
• protect from excessive moisture
• TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING FROM BOTTLE.

Inactive ingredients

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

Questions or comments?

1-800-645-2158

Principal Display Panel

Chlorpheniramine Maleate
4 mg

INGREDIENTS AND APPEARANCE

CHLORPHENIRAMINE MALEATE 
chlorpheniramine maleate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55289-560(NDC:0536-1006)
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
STARCH, CORN (UNII: O8232NY3SJ)
D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (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: 55289-560-24	24 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/26/2011
2	NDC: 55289-560-30	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/26/2011
3	NDC: 55289-560-01	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/26/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	12/19/1992

Labeler - PD-Rx Pharmaceuticals, Inc. (156893695)

Registrant - PD-Rx Pharmaceuticals, Inc. (156893695)

Establishment
Name	Address	ID/FEI	Business Operations
PD-Rx Pharmaceuticals, Inc.		156893695	repack(55289-560)