ED-CHLORTAN- chlorpheniramine maleate tablet, coated 
EDWARDS PHARMACEUTICALS, INC.

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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ED-CHLORTAN

Drug Facts

Active Ingredient (in each tablet)

Chlorpheniramine Maleate 4mg

Purpose

Antihistamine

Description

Ed Chlortan Tablets are yellow, round, plain bottom, debossed "PH above 012" on top.

Uses

temporarily relieves these symptoms due to hay fever (allergic rhinitis) 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.
  • May cause drowsiness
  • Avoid alcoholic beverages when taking this product.
  • Alcohol, sedatives and tranquilizers may increase drowsiness effect.
  • Use caution when driving a motor vehicle or operating machinery.

If pregnant or breast-feeding, ask a doctor before use.

Keep out of reach of children. In case of an overdose, get medical help or contact a Poison Control Center right away.

Directions

Do not exceed recommended dosage.

Adults and children 12 years of age and older.One tablet every 4 to 6 hours. Do not exceed 6 tablets in 24 hours.
Children 4 years to 12 yearsAsk a doctor
Children under 4 yearsDo not use

Other Information

  • Tamper Evident: Do Not Use If Safety Seal Under Cap Is Broken or Missing
  • Store at controlled room temperature 15°-25°C (59°-77°F)
  • Protect from excessive moisture

Inactive Ingredients

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

Questions or Comments?

Call 1-800-543-9560

Distributed by: Edwards Pharmaceuticals, Inc. • Ripley, MS 38663

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

E

NDC 0485-0085-01

ED-CHLORTAN
ANTIHISTAMINE

Chlorpheniramine Maleate 4mg

RELIEVES: RUNNY NOSE, SNEEZING, ITCHY
THROAT, ITCHY WATERY EYES

100 Tablets

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label
ED-CHLORTAN 
chlorpheniramine maleate tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0485-0085
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)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColoryellowScore2 pieces
ShapeROUNDSize6mm
FlavorImprint Code PH;012
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0485-0085-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/07/201102/15/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/07/201102/15/2017
Labeler - EDWARDS PHARMACEUTICALS, INC. (195118880)

Revised: 1/2022
Document Id: d57f8c18-dff0-0fd4-e053-2995a90abc70
Set id: 9ca71d93-2d32-4a74-8a5a-39ef446067e0
Version: 3
Effective Time: 20220113
 
EDWARDS PHARMACEUTICALS, INC.