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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Drug Facts 097

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:

Warnings


Ask a doctor before use if you have,

Ask a doctor or pharmacist before use if you

are taking sedatives or tranquilizers

When using this product

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

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.

image of label
CHLORPHENIRAMINE MALEATE 
chlorpheniramine maleate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67046-097(NDC:66424-034)
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
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
ColoryellowScoreno score
ShapeROUNDSize8mm
FlavorImprint Code PH012
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67046-097-1414 in 1 BLISTER PACK; Type 0: Not a Combination Product09/19/2017
2NDC:67046-097-077 in 1 BLISTER PACK; Type 0: Not a Combination Product09/19/2017
3NDC:67046-097-1515 in 1 BLISTER PACK; Type 0: Not a Combination Product09/19/2017
4NDC:67046-097-2121 in 1 BLISTER PACK; Type 0: Not a Combination Product09/19/2017
5NDC:67046-097-2828 in 1 BLISTER PACK; Type 0: Not a Combination Product09/19/2017
6NDC:67046-097-3030 in 1 BLISTER PACK; Type 0: Not a Combination Product09/19/2017
7NDC:67046-097-6060 in 1 BLISTER PACK; Type 0: Not a Combination Product09/19/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/19/2017
Labeler - Contract Pharmacy Services-PA (945429777)
Establishment
NameAddressID/FEIBusiness Operations
Coupler Enterprises945429777repack(67046-097)

Revised: 9/2017
Document Id: 598dd7ef-5049-c6dd-e053-2991aa0a87a2
Set id: 598dd7ef-5048-c6dd-e053-2991aa0a87a2
Version: 1
Effective Time: 20170919
 
Contract Pharmacy Services-PA