Rescon JR

Dosage form: tablet, multilayer
Ingredients: DEXCHLORPHENIRAMINE MALEATE 1mg, PSEUDOEPHEDRINE HYDROCHLORIDE 30mg
Labeler: Capellon Pharmaceuticals, LLC
NDC Code: 64543-086

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.

RESCON® JR

Drug Facts

Active Ingredients (per tablet)

Dexchlorpheniramine Maleate 1 mg

Pseudoephedrine Hydrochloride 30 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): 2 tablets 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 ingredients

colloidal silicon dioxide, crospovidone polyplasdone, D&C Yellow #10, 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

RESCON JR 
dexchlorpheniramine maleate and pseudoephedrine hydrochloride tablet, multilayer
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64543-086
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXCHLORPHENIRAMINE MALEATE (DEXCHLORPHENIRAMINE) DEXCHLORPHENIRAMINE MALEATE1 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
CROSPOVIDONE 
D&C YELLOW NO. 10 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POVIDONE K30 
Product Characteristics
ColorYELLOW, WHITEScoreno score
ShapeOVALSize15mm
FlavorImprint CodeRESJR11
Contains    
Packaging
#Item CodePackage Description
1NDC:64543-086-9090 TABLET, MULTILAYER (TABLET) in 1 BOTTLE
2NDC:64543-086-021 TABLET, MULTILAYER (TABLET) in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/30/201204/30/2014
Labeler - Capellon Pharmaceuticals, LLC (124568093)
Establishment
NameAddressID/FEIOperations
Sovereign Pharmaceuticals, LLC623168267MANUFACTURE(64543-086)

Revised: 02/2014
 
Capellon Pharmaceuticals, LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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