CHLORPHENIRAMINE MALEATE- chlorpheniramine maleate tablet 
Contract Pharmacy Services-PA

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

Active ingredient

Chlorpheniramine maleate 4 mg

Purpose

Antihistamine

Uses

Warnings

Do not use

to make a child sleepy

Ask a doctor before use if you have

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

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

When using this product

  • alcohol, sedatives and tranquilizers may increase drowsiness
  • drowsiness may occur
  • avoid alcoholic drinks
  • excitability may occur, especially in children
  • be careful 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

take every 4 to 6 hours, not more than 6 doses in 24 hours

adults and children 12 years of age and over1 tablet (4 mg)
children 6 to under 12 years of age1/2 tablet (2 mg)
children 4 to under 6 years of age

do not use unless

directed by a doctor
children under 4 years of agedo not use

Inactive ingredients

D&C yellow #10 lake, lactose, magnesium stearate, microcrystalline cellulose, pregelatinized starch.

QUESTIONS OR COMMENTS?

Distributed by:

Major Pharmaceuticals

31778 Enterprise Drive

Livonia, MI 48150, USA

1-734-743-6000

Repackaged by:

Contract Pharmacy Services-PA
125 Titus Ave Suite 200
Warrington, PA 18976 USA

Original--01/2011--NJW

Package/Label Principal Display Panel

Blister of 30 Tablets

Blister of 30 Tablets

CHLORPHENIRAMINE MALEATE 
chlorpheniramine maleate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67046-089(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
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
LACTOSE (UNII: J2B2A4N98G)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorYELLOWScore2 pieces
ShapeROUNDSize8mm
FlavorImprint Code 44;194
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67046-089-1414 in 1 BLISTER PACK
2NDC:67046-089-3030 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/10/2011
Labeler - Contract Pharmacy Services-PA (945429777)

Revised: 1/2011
Document Id: 4ea37cb2-af4c-4fad-bcc4-c7a0e8101e9f
Set id: 4ea37cb2-af4c-4fad-bcc4-c7a0e8101e9f
Version: 1
Effective Time: 20110110
 
Contract Pharmacy Services-PA