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ACTICON by ACTIPHARMA, INC

Medically reviewed on October 13, 2016

Dosage form: liquid
Ingredients: DEXBROMPHENIRAMINE MALEATE 1mg in 5mL, PSEUDOEPHEDRINE HYDROCHLORIDE 30mg in 5mL
Labeler: ACTIPHARMA, INC
NDC Code: 63102-105

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

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

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 take this product if you are taking sedatives or tranquilizers, without first consulting

your 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

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.

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

Keep out of reach of children.

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

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

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:

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

• Store at controlled room temperature 15°- 30ºC (59°- 86ºF)

• Avoid excessive heat or humidity.

Inactive Ingredients:

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

ACTICON 
dexbrompheniramine maleate, pseudoephedrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63102-105
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXBROMPHENIRAMINE MALEATE (DEXBROMPHENIRAMINE) DEXBROMPHENIRAMINE MALEATE1 mg  in 5 mL
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
GLYCERIN 
METHYLPARABEN 
PROPYLENE GLYCOL 
PROPYLPARABEN 
WATER 
SODIUM CITRATE 
sucralose 
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:63102-105-16480 mL in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/14/2016
Labeler - ACTIPHARMA, INC (079340948)
Registrant - ACTIPHARMA, INC (079340948)

 
ACTIPHARMA, INC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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