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NDC 63102-0105-16 ACTICON 1; 30 mg/5mL; mg/5mL Details
ACTICON 1; 30 mg/5mL; mg/5mL
ACTICON is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by ACTIPHARMA, INC.. The primary component is DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Brompheniramine relieves red, irritated, itchy, watery eyes; sneezing; and runny nose caused by allergies, hay fever, and the common cold. Brompheniramine helps control symptoms, but does not treat the cause of the symptoms or speed recovery. Brompheniramine should not be used to cause sleepiness in children. Brompheniramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.
Related Packages: 63102-0105-16Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Brompheniramine
Product Information
| NDC | 63102-0105 |
|---|---|
| Product ID | 63102-105_f7745a70-8cca-4466-923f-242ba9fb6a82 |
| Associated GPIs | 43993002542020 |
| GCN Sequence Number | 063799 |
| GCN Sequence Number Description | dexbrompheniramine/pseudoephed SOLUTION 1MG-30MG/5 ORAL |
| HIC3 | Z2N |
| HIC3 Description | 1ST GEN ANTIHISTAMINE AND DECONGESTANT COMBINATION |
| GCN | 99509 |
| HICL Sequence Number | 000507 |
| HICL Sequence Number Description | DEXBROMPHENIRAMINE MALEATE/PSEUDOEPHEDRINE HCL |
| Brand/Generic | Brand |
| Proprietary Name | ACTICON |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Dexbrompheniramine maleate, pseudoephedrine hydrochloride |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LIQUID |
| Route | ORAL |
| Active Ingredient Strength | 1; 30 |
| Active Ingredient Units | mg/5mL; mg/5mL |
| Substance Name | DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE |
| Labeler Name | ACTIPHARMA, INC. |
| Pharmaceutical Class | Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 63102-0105-16 (63102010516)
| NDC Package Code | 63102-105-16 |
|---|---|
| Billing NDC | 63102010516 |
| Package | 480 mL in 1 PACKAGE (63102-105-16) |
| Marketing Start Date | 2016-07-14 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 43fa98a5-02c7-4179-aae2-3994b2357bc6 Details
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 accompanined by fever • new symptoms occur
If pregnant or breast feeding, ask a health professional before use.
Directions:
• Adults and children 12 years of age and over: Take 2 teaspoonfuls (10 mL) every 4-6 hours as needed, do not exceed 4 teaspoonfuls in 24 hours, or as directed by a doctor.
• Children 6-12 years: Take 1 teaspoonful (5 mL) every 4-6 hours as needed, do not exceed 2 teaspoonfuls in 24 hours, or as directed by a doctor.
• Children under 6 years of age: consult a doctor.
Other Information:
Inactive Ingredients:
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
| ACTICON
dexbrompheniramine maleate, pseudoephedrine hydrochloride liquid |
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| Labeler - ACTIPHARMA, INC. (079340948) |
| Registrant - ACTIPHARMA, INC. (079340948) |