RESCON- dexchlorpheniramine maleate and pseudoephedrine hydrochloride tablet, multilayer 
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® Tablets

Drug Facts

Active Ingredients (per tablet)

Dexchlorpheniramine Maleate 2 mg

Pseudoephedrine Hydrochloride 60 mg

Purpose

Dexchlorpheniramine Maleate Antihistamine

Pseudoephedrine Hydrochloride Nasal Decongestant

Uses

For the temporary relief of

  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes due to hay fever or other upper respiratory allergies
  • nasal congestion

Temporarily helps

  • clear nasal passages
  • shrink swollen membranes

Warnings

  • Do not exceed recommended dosage
  • May cause excitability especially in children
  • May cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect.

When using this product

  • Avoid alcoholic beverages
  • Use caution when driving a motor vehicle or operating machinery.

Do not use

  • If you have a breathing problem such as emphysema or chronic bronchitis
  • 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

Stop use and ask a doctor

  • If nervousness, dizziness, or sleeplessness occur.
  • If symptoms do not improve within 7 days or are accompanied by fever.

Ask a doctor before use if you have

  • glaucoma
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to enlargement of the prostate gland
  • or if you are taking sedatives or tranquilizers

If pregnant or breast feeding

Ask a health professional before use.

Keep out of the reach of children

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

Directions

  • Adults (12 and older): One tablet every 4 to 6 hours. Not to exceed 4 doses in 24 hours.
  • Children under 12 years of age: Consult a physician.

Other information

store at 20°-25°C (68°-77°F)

Inactive ingredient

colloidal silicon dioxide, crospovidone polyplasdone, D&C Red #30, D&C Yellow #10, FD&C Blue #1, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone

Questions or Comments?

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Figure 1: 90 ct product label

figure-01
RESCON 
dexchlorpheniramine maleate and pseudoephedrine hydrochloride tablet, multilayer
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64543-097
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXCHLORPHENIRAMINE MALEATE (UNII: B10YD955QW) (DEXCHLORPHENIRAMINE - UNII:3Q9Q0B929N) DEXCHLORPHENIRAMINE MALEATE2 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE60 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSPOVIDONE (UNII: 2S7830E561)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POVIDONE K30 (UNII: U725QWY32X)  
Product Characteristics
Coloryellow, purpleScoreno score
ShapeOVALSize15mm
FlavorImprint Code RES11
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64543-097-9090 in 1 BOTTLE; Type 0: Not a Combination Product03/30/201202/28/2021
2NDC:64543-097-021 in 1 POUCH; Type 0: Not a Combination Product03/30/201202/28/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/30/201202/28/2021
Labeler - Capellon Pharmaceuticals, LLC (124568093)

Revised: 8/2023
 
Capellon Pharmaceuticals, LLC