ACTICON- dexbrompheniramine maleate, pseudoephedrine hydrochloride liquid

ACTICON by

Drug Labeling and Warnings

ACTICON by is a Otc medication manufactured, distributed, or labeled by ACTIPHARMA, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients (in each 5 mL tsp)

Dexbrompheniramine Maleate, 1 mg

Pseudoephedrine HCl, 30 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 accompanined by fever new symptoms occur

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

Keep out of reach of children. 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

SPL UNCLASSIFIED SECTION

Contains the same active ingredients as Conex®*

Manufactured in the USA for ActiPharma, Inc.

Dorado, PR 00646. Tel: (787) 608-0882

* Conex® is a registered trademark of Llorens

Pharmaceutical Corp. This product is not manufactured, distributed or marketed by Llorens Pharmaceutical Corp.

Packaging

INGREDIENTS AND APPEARANCE

ACTICON 
dexbrompheniramine maleate, pseudoephedrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63102-105
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXBROMPHENIRAMINE MALEATE (UNII: BPA9UT29BS) (DEXBROMPHENIRAMINE - UNII:75T64B71RP)	DEXBROMPHENIRAMINE MALEATE	1 mg  in 5 mL
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	30 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63102-105-16	480 mL in 1 PACKAGE; Type 0: Not a Combination Product	07/14/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	07/14/2016

Labeler - ACTIPHARMA, INC. (079340948)

Registrant - ACTIPHARMA, INC. (079340948)