FDA Label for Acticon

View Indications, Usage & Precautions

Acticon Product Label

The following document was submitted to the FDA by the labeler of this product Actipharma, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Active Ingredients/5 ml:Dexbrompheniramine Maleate 1 mg, Pseudoephedrine HCl 30 mg


Otc - Purpose



Antihistamine, nasal decongestant


Indications & Usage



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



Warnings:

Do not exceed recommended dosage

Do not take this product if you are taking sedatives or tranquilizers, without first consulting

your doctor.


Otc - Ask Doctor



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.

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


Otc - Do Not Use



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.


Otc - When Using



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


Otc - Keep Out Of Reach Of Children



Keep out of reach of children.


Otc - Pregnancy Or Breast Feeding



If pregnant or breast feeding, ask a health professional before use.


Overdosage



In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.


Dosage & Administration



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 Safety Information



Other Information:

• Tamper Evident. Do not use if inner seal is torn, cut, or opened.

• Store at controlled room temperature 15°- 30°C (59°- 86°F)

• Avoid excessive heat or humidity.


Inactive Ingredient



Inactive Ingredients:

citric acid, flavor, glycerin, methyl paraben, propylene glycol, propyl paraben, purified water, sodium citrate, sucralose


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