G-con-x

G-con-x
SPL v1
SPL
SPL Set ID eba7a410-4ad9-40e8-80f5-18a656317152
Route
ORAL
Published
Effective Date 2014-04-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dexbrompheniramine (1 mg) Pseudoephedrine (30 mg)
Inactive Ingredients
Sodium Benzoate Citric Acid Monohydrate Sorbitol Saccharin Sodium Sucralose Propylene Glycol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2014-02-11

Description

Drug Facts


Medication Information

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1
  • Keep this and all drugs out of the reach of children.
Section 50567-7
  • May cause excitability especially in children.
Section 50568-5
  • In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.
Section 50569-3
  • 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.
Section 50570-1
  • 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.
Section 53414-9
  • If pregnant or breast-feeding, ask a health professional before use.
Section 55105-1
Active Ingredients (in each 5 mL, teaspoonful) Purpose
Pseudoephedrine HCl 30 mg Nasal Decongestant
Dexbrompheniramine Maleate 1 mg Antihistamine
Directions

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

Adults and children 12 years of age and over 2 teaspoonfuls (10 mL) every 4 to 6 hours
Children 6 to under 12 years of age 1 teaspoonful (5 mL) every 4 to 6 hours
Children under 6 years of age Consult a doctor
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.
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.

Inactive Ingredients

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

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


Structured Label Content

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)
  • Keep this and all drugs out of the reach of children.
Section 50567-7 (50567-7)
  • May cause excitability especially in children.
Section 50568-5 (50568-5)
  • In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.
Section 50569-3 (50569-3)
  • 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.
Section 50570-1 (50570-1)
  • 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.
Section 53414-9 (53414-9)
  • If pregnant or breast-feeding, ask a health professional before use.
Section 55105-1 (55105-1)
Active Ingredients (in each 5 mL, teaspoonful) Purpose
Pseudoephedrine HCl 30 mg Nasal Decongestant
Dexbrompheniramine Maleate 1 mg Antihistamine
Directions

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

Adults and children 12 years of age and over 2 teaspoonfuls (10 mL) every 4 to 6 hours
Children 6 to under 12 years of age 1 teaspoonful (5 mL) every 4 to 6 hours
Children under 6 years of age Consult a doctor
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.
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.

Inactive Ingredients

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

Principal Display Panel 473 Ml Bottle Label (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


Advanced Ingredient Data


Raw Label Data

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