RESCON DM- chlorpheniramine maleate, dextromethorphan hydrobromide, and pseudoephedrine hydrochloride liquid 
Capellon Pharmaceuticals, LLC

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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Rescon DM

Drug Facts

Active Ingredients

Chlorpheniramine Maleate 2 mg

Dextromethorphan HBr 10 mg

Pseudoephedrine HCl, USP 30 mg

Purpose

Chlorpheniramine Maleate Antihistamine

Dextromethorphan HBr Antitussive (cough suppressant)

Pseudoephedrine HCl Nasal Decongestant

Usage

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

  • cough due to minor throat and bronchial irritation
  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat
  • nasal congestion
  • temporarily restores freer breathing through the nose

Warnings

Do not use

  • to sedate a child or make a child sleepy
  • 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 drug.

Ask a doctor before use if you have.

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
  • a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
  • a cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if you are

  • taking any other nasal decongestant or stimulant
  • taking sedatives or tranquilizers

When using this product

Do not exceed recommended dosage.

  • marked drowsiness may occur
  • avoid alcoholic beverages
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

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.

If pregnant or breast feeding

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 4 doses in a 24 hour period.

Age Dose
Adults and children over 12 years of age2 teaspoonsful (10 mL) every 4 hours
Children 6 to under 12 years of age1 teaspoonsful (5 mL) every 4 hours
Children under 6 years of ageAsk your doctor

Other Information

  • store at 20°-25°C (68°-77°F)
  • tamper evident: do not use if foil seal under the cap is broken or missing
  • contains less than 1 mg sodium in each 5 mL teaspoonful

Inactive Ingredients

cherry flavor, methylparaben, polyethylene glycol, propylparaben, purified water, saccharin sodium, and sorbitol

Questions or Comments?

Serious side effects may be reported to this number, call (817) 595-5820. (8 am to 5 pm CST)

Principal Display Panel

Figure 1: 16 oz. bottle label

85cac3dd-figure-01
RESCON DM 
chlorpheniramine maleate, dextromethorphan hydrobromide, and pseudoephedrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64543-105
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64543-105-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/199909/30/2021
2NDC:64543-105-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/199909/30/2021
3NDC:64543-105-0125 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/199909/30/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/01/199909/30/2021
Labeler - Capellon Pharmaceuticals, LLC (124568093)
Establishment
NameAddressID/FEIBusiness Operations
Sovereign Pharmaceuticals, LLC623168267manufacture(64543-105)

Revised: 8/2023
 
Capellon Pharmaceuticals, LLC