ED-A-HIST DM- chlorpheniramine maleate, dextromethorphan hydrobromide, and phenylephrine hydrochloride tablet 
Syntho 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 A-HIST DM TABLETS

Drug Facts

Active Ingredients (in each tablet)Purpose
Chlorpheniramine Maleate 4 mgAntihistamine
Dextromethorphan HBr 10 mgAntitussive
Phenylephrine HCl 10 mgNasal Decongestant

Uses

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other respiratory allergies:

Warnings

Do not use this product

  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Do not use this product, unless directed by a doctor, if you have

  • a breathing problem such as emphysema or chronic bronchitis.
  • glaucoma.
  • a persistent or chronic cough that occurs with too much phlegm (mucus).
  • heart disease.
  • high blood pressure.
  • thyroid disease.
  • diabetes mellitus.
  • difficulty in urination due to enlargement of the prostate gland.

Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor.

When using this product

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

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur.
  • cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. These could be signs of a serious condition.
  • new symptoms occur.

If pregnant or breastfeeding, ask a health professional before use.

Keep out of reach of children. In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.

Directions

Do not exceed recommended dosage.

Adults and children 12 years of age and over:1 tablet every 4 hours, not to exceed 6 tablets in 24 hours, or as directed by a doctor
Children 6 to under 12 years of age:1/2 tablet every 4 hours, not to exceed 3 tablets in 24 hours, or as directed by a doctor
Children under 6 years of age:Consult a doctor.

Inactive ingredients

Lactose Monohydrate, Microcrystalline Cellulose, Magnesium Stearate, HPMC, Propylene Glycol, Titanium Dioxide, D&C Red #27, Blue #1.

Questions or Comments?

Call 1-800-664-1490   Rev. 9/22

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 66576-240-01

ED A-HIST DM TABLETS

Antihistamine • Antitussive • Nasal Decongestant

Each tablet contains:

Chlorpheniramine Maleate .............. 4 mg
Dextromethorphan HBr.................. 10 mg
Phenylephrine HCl......................... 10 mg

Store at 59°-86°F (15°-30°C) [see USP Controlled Room Temperature].
Tamper evident by foil seal under cap.
Do not use if foil seal is broken or missing.

Manufactured for:
EDWARDS
Pharmaceuticals, Inc.
Berwyn, PA 19312

100 tablets

image description

ED-A-HIST DM 
chlorpheniramine maleate, dextromethorphan hydrobromide, and phenylephrine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66576-240
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE4 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Product Characteristics
ColorpurpleScore2 pieces
ShapeOVALSize16mm
FlavorImprint Code ED;DM
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66576-240-01100 in 1 BOTTLE; Type 0: Not a Combination Product11/02/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34111/02/2022
Labeler - Syntho Pharmaceuticals, Inc. (088797407)
Registrant - Syntho Pharmaceuticals, Inc. (088797407)
Establishment
NameAddressID/FEIBusiness Operations
Syntho Pharmaceuticals, Inc.088797407manufacture(66576-240)

Revised: 11/2022
Document Id: ec8ad36b-66b4-8820-e053-2995a90ad76d
Set id: ca13b8c2-022b-4eab-a573-8e4a65e33130
Version: 1
Effective Time: 20221103
 
Syntho Pharmaceuticals, Inc.