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Rescon

Capellon Pharmaceuticals, LLC




FULL PRESCRIBING INFORMATION

Drug Facts

Dexchlorpheniramine Maleate  2 mg

Pseudoephedrine Hydrochloride  60 mg

Dexchlorpheniramine Maleate          Antihistamine

Pseudoephedrine Hydrochloride       Nasal Decongestant

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
  • Do not exceed recommended dosage
  • May cause excitability especially in children
  • ∙May cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect.
  • ∙Avoid alcoholic beverages
  • ∙Use caution when driving a motor vehicle or operating machinery.
  • ∙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
  • ∙If nervousness, dizziness, or sleeplessness occur.
  • ∙If symptoms do not improve within 7 days or are accompanied by fever.
  • ∙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

Ask a health professional before use.

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

  • 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.

store at 20°-25°C (68°-77°F)

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

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

Figure 1: 90 ct product label

Rescon

Rescon

Dexchlorpheniramine Maleate and Pseudoephedrine Hydrochloride TABLET, MULTILAYER

Product Information

Product Type Human otc drug label Item Code (Source) NDC:64543-097
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Dexchlorpheniramine Maleate DEXCHLORPHENIRAMINE 2 mg
Pseudoephedrine Hydrochloride Pseudoephedrine 60 mg

Inactive Ingredients

Ingredient Name Strength
SILICON DIOXIDE
CROSPOVIDONE
D&C RED NO. 30
D&C YELLOW NO. 10
FD&C BLUE NO. 1
lactose monohydrate
MAGNESIUM STEARATE
cellulose, microcrystalline
POVIDONE K30

Product Characteristics

Color Size Imprint Code Shape
PURPLE 15 mm RES11 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:64543-097-90 90 in 1 BOTTLE
2 NDC:64543-097-02 1 in 1 POUCH

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2012-03-30


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