Acticon Solution
FDA Label NDC 63102-108
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Actipharma, Llc for the product Acticon (NDC 63102-108). 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 drug facts, active ingredients (in each 5 ml tsp), purpose, uses, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients (In Each 5 Ml Tsp)
Dexbrompheniramine Maleate, USP 2 mg
Pseudoephedrine HCl, USP 60 mg
Purpose
Antihistamine
Nasal Decongestant
Uses
• Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:
• relieves sinus congestion and pressure, helps decongest sinus openings and passages
• restores freer breathing through the nose
• runny nose • sneezing • itching of the nose or throat • itchy, watery eyes • nasal congestion
Warnings
Do not exceed recommended dosage
Do not use this product
• 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.
Ask a doctor before use if you have
• a breathing problem such as emphysema or chronic bronchitis • glaucoma • heart disease • high blood pressure • thyroid disease • diabetes • difficulty in urination due to enlargement of the prostate gland
Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor.
When using this product
• excitability may occur, especially in children • may cause drowsiness • alcohol, sedatives and tranquilizers may increase drowsiness effect • avoid alcoholic beverages • use caution when driving a motor vehicle or operating machinery
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 • new symptoms occur
If pregnant or breast feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.
Directions
Do not exceed more than 4 doses in 24 hours, or as directed by a doctor.
| AGE | DOSE |
| Adults and children 12 years of age and over | 1 teaspoonful (5 ml) every 4-6 hours |
Other Information
• Tamper Evident Feature: Do not use if inner seal is torn, cut, or opened.
• Store at controlled room temperature 15°- 30°C (59°- 86°F).
Inactive Ingredients
Citric acid, flavor, methylparaben, potassium citrate, propylene glycol, propylparaben, purified water, sorbitol, sucralose.
Packaging
Cold & Allergy (63102 108 16)
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