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

Temporarily helps

Warnings

When using this product

Do not use

Stop use and ask a doctor

Ask a doctor before use if you have

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

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 Product03/30/2012
2NDC:64543-097-021 in 1 POUCH; Type 0: Not a Combination Product03/30/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/30/2012
Labeler - Capellon Pharmaceuticals, LLC (124568093)

Revised: 11/2022
Document Id: edfea55f-1a20-f40e-e053-2a95a90a9093
Set id: 9d08d801-6cca-4a1c-ab53-5979f16e3110
Version: 6
Effective Time: 20221121
 
Capellon Pharmaceuticals, LLC