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Drug Facts
G-con-x
FDA Label NDC 43913-405
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Mclaren Medical for the product G-con-x (NDC 43913-405). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - purpose, indications, otc - ask doctor, otc - do not use, otc - when using, otc - pregnancy or breast feeding, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active Ingredients (in each 5 mL, teaspoonful) | Purpose |
|---|---|
| Pseudoephedrine HCl 30 mg | Nasal Decongestant |
| Dexbrompheniramine Maleate 1 mg | Antihistamine |
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.
Otc - Ask Doctor
- 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.
Otc - Do Not Use
- 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.
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.
Otc - When Using
- May cause excitability especially in children.
- May cause drowsiness; alcohol, sedatives and tranquilizers may increase the drowsiness effect.
Avoid alcoholic beverages while taking this product.
Otc - Pregnancy Or Breast Feeding
- If pregnant or breast-feeding, ask a health professional before use.
Otc - Ask Doctor/Pharmacist
- In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.
Otc - Keep Out Of Reach Of Children
- 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 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 |
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)
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