CHLORPHENIRAMINE MALEATE tablet

Chlorpheniramine Maleate by

Drug Labeling and Warnings

Chlorpheniramine Maleate by is a Otc medication manufactured, distributed, or labeled by Contract Pharmacy Services-PA, Coupler Enterprises. 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 nose or throat
• itchy watery eyes
• sneezing

Warnings

Ask a doctor before use if you have,

• a breathing problem such as emphysema or chronic bronchitis
• glaucoma
• trouble urinating due to enlarged prostate gland
  

Ask a doctor or pharmacist before use if you

are taking sedatives or tranquilizers

When using this product

• excitability may occur, especially in children
• drowsiness may occur
• avoid alcoholic beverages
• alcohol, sedatives and tranquilizers may increase drowsiness
• use caution when driving a motor vehicle or operating machinery
  

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.

Directions

• adults and children 12 years of age and older: one tablet 4 to 6 hours, not to exceed 6 tablets in 24 hours
• children 6 to under 12 years of age: 1/2 tablet every 4 to 6 hours, not to exceed 3 whole tablets in 24 hours
• children under 6 years of age: consult a physician

Other information

• Tamper Evident: Do not Use If Safety Seal Under Cap Is Broken Or Missing
• store at controlled room temperature 15 o-25 oC (59 o-77 oF)
• protect from excessive moisture
  

Inactive ingredients: corn starch, croscarmellose sodium, D&C yellow # 10 aluminum lake 14-18%, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silicon dioxide

Questions:

To Report Adverse Drug Events Call 800-687-0176.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CHLORPHENIRAMINE MALEATE 
chlorpheniramine maleate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67046-097(NDC:66424-034)
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)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	yellow	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	PH012
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67046-097-14	14 in 1 BLISTER PACK; Type 0: Not a Combination Product	09/19/2017
2	NDC: 67046-097-07	7 in 1 BLISTER PACK; Type 0: Not a Combination Product	09/19/2017
3	NDC: 67046-097-15	15 in 1 BLISTER PACK; Type 0: Not a Combination Product	09/19/2017
4	NDC: 67046-097-21	21 in 1 BLISTER PACK; Type 0: Not a Combination Product	09/19/2017
5	NDC: 67046-097-28	28 in 1 BLISTER PACK; Type 0: Not a Combination Product	09/19/2017
6	NDC: 67046-097-30	30 in 1 BLISTER PACK; Type 0: Not a Combination Product	09/19/2017
7	NDC: 67046-097-60	60 in 1 BLISTER PACK; Type 0: Not a Combination Product	09/19/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	09/19/2017

Labeler - Contract Pharmacy Services-PA (945429777)

Establishment
Name	Address	ID/FEI	Business Operations
Coupler Enterprises		945429777	repack(67046-097)