RESCON MX- dexchlorpheniramine maleate tablet 
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 MX

DrugFacts

Active Ingredients

Dexchlorpheniramine Maleate, USP 2 mg

Purpose

Dexchlorpheniramine Maleate Antihistamine

Uses

Temporarily relieves these symptoms due to hay fever (allergic rhinitis):

  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat

Warnings

May cause excitability especially in children

Ask a doctor before use if you have

  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
  • are taking sedatives or tranquilizers

When using this product

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

If pregnant or breast feeding

  • ask a health professional before use.

Keep out of reach of children

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

Directions

Do not exceed 6 doses in a 24-hour period

AgeDose
Adults and children over 12 years of age1 tablet every 4 to 6 hours
Children under 12 years of ageConsult with a physician

Other information

store at 20°-25°C (68°-77°F)

Inactive Ingredients

colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid.

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: Product Label

dcc88ac4-figure-01
RESCON MX 
dexchlorpheniramine maleate tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:64543-092
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXCHLORPHENIRAMINE MALEATE (DEXCHLORPHENIRAMINE) DEXCHLORPHENIRAMINE MALEATE2 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POVIDONE K30 
STARCH, CORN 
STEARIC ACID 
Product Characteristics
ColorWHITEScoreno score
ShapeOVAL (modified) Size12mm
FlavorImprint Code DEXC
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64543-092-9090 in 1 BOTTLE
2NDC:64543-092-2012 in 1 CARTON
21 in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/28/201107/31/2013
Labeler - Capellon Pharmaceuticals, LLC (124568093)
Registrant - Capellon Pharmaceuticals, LLC (124568093)
Establishment
NameAddressID/FEIBusiness Operations
Sovereign Pharmaceuticals, LLC623168267MANUFACTURE(64543-092)

Revised: 2/2014
Document Id: c8bcf27b-59e5-4b3f-a9d6-7df6267ecdbd
Set id: 3e9a1b25-6fb4-4790-af1c-77a995f2f8c8
Version: 2
Effective Time: 20140212
 
Capellon Pharmaceuticals, LLC