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Chlorpheniramine Maleate by SDA Laboratories, Inc.

Dosage form: tablet
Ingredients: Chlorpheniramine Maleate 4mg
Labeler: SDA Laboratories, Inc.
NDC Code: 66424-034

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.

Drug Facts

Active ingredient(in each tablet)Chlorpheniramine Maleate 4 mg

PurposeAntihistamine

UsesTemporarily 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 youare 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 15o-25oC (59o-77oF)
  • 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.

CHLORPHENIRAMINE MALEATE 
chlorpheniramine maleate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66424-034
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Chlorpheniramine Maleate (Chlorpheniramine) Chlorpheniramine Maleate4 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN  
CROSCARMELLOSE SODIUM 
D&C YELLOW NO. 10 
ANHYDROUS DIBASIC CALCIUM PHOSPHATE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE  
SILICON DIOXIDE  
Product Characteristics
ColoryellowScoreno score
ShapeROUNDSize8mm
FlavorImprint CodePH012
Contains    
Packaging
#Item CodePackage Description
1NDC:66424-034-01100 TABLET (TABLET) in 1 BOTTLE, PLASTIC
2NDC:66424-034-101000 TABLET (TABLET) in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/19/2010
Labeler - SDA Laboratories, Inc. (948067889)
Registrant - Pharbest Pharmaceuticals, Inc. (557054835)
Establishment
NameAddressID/FEIOperations
Pharbest Pharmaceuticals, Inc.557054835manufacture

 
SDA Laboratories, Inc.

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Medically reviewed on Nov 15, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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