G-CON-X- dexbrompheniramine maleate and pseudoephedrine hydrochloride liquid 
McLaren Medical

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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G-Con-X

Drug Facts

Active Ingredients (in each 5 mL, teaspoonful)Purpose
Pseudoephedrine HCl 30 mgNasal Decongestant
Dexbrompheniramine Maleate 1 mgAntihistamine

Indications

Warnings

  • Do not exceed recommended dosage.
    If nervousness, dizziness or sleeplessness occurs, discontinue use and consult a doctor.
  • If symptoms do not improve within 7 days or are accompanied by fever, consult a doctor.

  • Do not take this product if you have heart disease, high blood pressure, thyroid disease, diabetes or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.
  • Do not use 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.

  • May cause excitability especially in children.

  • Do not take this product, unless directed by a doctor, if you have a breathing problem such as emphysema or chronic bronchitis or if you have glaucoma or difficulty in urination due to the enlargement of the prostate gland.

  • May cause drowsiness; alcohol, sedatives and tranquilizers may increase the drowsiness effect.

Avoid alcoholic beverages while taking this product.

Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor. Use caution when driving a motor vehicle or operating machinery.

  • If pregnant or breast-feeding, ask a health professional before use.

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

  • Keep this and all drugs out of the reach of children.

Directions

Do not take more than 6 doses in any 24-hour period.

Adults and children 12 years of age and over2 teaspoonfuls (10 mL) every 4 to 6 hours
Children 6 to under 12 years of age1 teaspoonful (5 mL) every 4 to 6 hours
Children under 6 years of ageConsult a doctor

Inactive Ingredients

Citric Acid, Grape Flavor, Propylene Glycol, Purified Water, Saccharine Sodium, Sodium Benzoate, Sorbitol, Sucralose.

Other Information

Store at 20°-25°C (68°-77°F)

Tamper evident by seal under cap. Do not use if the seal is broken or missing.

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

NDC-43913-405-16

G-Con-X

Antihistamine & Nasal Decongestant

Sugar Free • Dye Free • Alcohol Free • Phenylalanine Free

Grape Flavor

16 FL OZ (473 mL)

Multiple Dose Unit Package
For Dispensing Under Pharmaceutical Supervision Only

McLaren Medical

Principal Display Panel - 473 mL Bottle Label
G-CON-X 
dexbrompheniramine maleate and pseudoephedrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43913-405
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dexbrompheniramine Maleate (UNII: BPA9UT29BS) (Dexbrompheniramine - UNII:75T64B71RP) Dexbrompheniramine Maleate1 mg  in 5 mL
Pseudoephedrine Hydrochloride (UNII: 6V9V2RYJ8N) (Pseudoephedrine - UNII:7CUC9DDI9F) Pseudoephedrine Hydrochloride30 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Sodium Benzoate (UNII: OJ245FE5EU)  
Citric Acid Monohydrate (UNII: 2968PHW8QP)  
Sorbitol (UNII: 506T60A25R)  
Saccharin Sodium (UNII: SB8ZUX40TY)  
Sucralose (UNII: 96K6UQ3ZD4)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Water (UNII: 059QF0KO0R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43913-405-16473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34102/11/2014
Labeler - McLaren Medical (013770591)
Registrant - davAgen Pharmaceutical, LLC (967545935)
Establishment
NameAddressID/FEIBusiness Operations
davAgen Pharmaceutical, LLC967545935MANUFACTURE(43913-405) , PACK(43913-405) , LABEL(43913-405) , ANALYSIS(43913-405)

Revised: 4/2014
Document Id: fd524b39-a374-4991-8388-9a8554d9d844
Set id: eba7a410-4ad9-40e8-80f5-18a656317152
Version: 1
Effective Time: 20140423
 
McLaren Medical