![G-CON-X (DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [MCLAREN MEDICAL]](https://medic.hrt.org//dailymed/images/eba7a410-4ad9-40e8-80f5-18a656317152/g-con-x-01.jpg)
| NDC | 43913-405-16 |
| Set ID | eba7a410-4ad9-40e8-80f5-18a656317152 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | McLaren Medical |
| Generic Name | |
| Product Class | alpha-Adrenergic Agonist |
| Product Number | |
| Application Number | PART341 |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
-
Indications
- For the temporary relief of nasal congestion due to the common cold, hay fever or other upper respiratory allergies (allergic rhinitis).
- Helps decongest sinus openings and passages; temporarily relieves sinus congestion and pressure.
- For the temporary relief of runny nose, sneezing, itching of the nose or throat and itchy, watery eyes due to hay fever or other respiratory allergies.
-
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.
- 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.
-
Do not exceed recommended dosage.
- Directions
- Inactive Ingredients
- Other Information
- PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
-
INGREDIENTS AND APPEARANCE
G-CON-X
dexbrompheniramine maleate and pseudoephedrine hydrochloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43913-405 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Dexbrompheniramine Maleate (UNII: BPA9UT29BS) (Dexbrompheniramine - UNII:75T64B71RP) Dexbrompheniramine Maleate 1 mg in 5 mL Pseudoephedrine Hydrochloride (UNII: 6V9V2RYJ8N) (Pseudoephedrine - UNII:7CUC9DDI9F) Pseudoephedrine Hydrochloride 30 mg in 5 mL Inactive Ingredients Ingredient Name Strength 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 Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43913-405-16 473 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 02/11/2014 Labeler - McLaren Medical (013770591) Registrant - davAgen Pharmaceutical, LLC (967545935) Establishment Name Address ID/FEI Business Operations davAgen Pharmaceutical, LLC 967545935 MANUFACTURE(43913-405) , PACK(43913-405) , LABEL(43913-405) , ANALYSIS(43913-405)
