ACTICON PEDIATRIC

Manufacturer
ACTIPHARMA, LLC
Effective date
2025-07-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:07:48

Label at a glance#

ProductACTICON PEDIATRIC
Active ingredientDEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

• Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other 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

Dosage and administration

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  2 teaspoonfuls (10 mL) every 4-6 hours  Children 6 to under 12 years of age  1 teaspoonful (5 mL) every 4-6 hours  Children under 6 years of age  ask a doctor

Storage and handling

• 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).

Label contents#

Full prescribing information#

Active ingredients (in each 5 mL tsp)

OTC - ACTIVE INGREDIENT SECTION

Dexbrompheniramine Maleate, USP 1 mg

Pseudoephedrine HCl, USP 30 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Nasal Decongestant

Uses

INDICATIONS & USAGE SECTION

• Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other 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 SECTION

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 • 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 SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Do not exceed more than 4 doses in 24 hours, or as directed by a doctor.

AGEDOSE
 Adults and children 12 years of age and over 2 teaspoonfuls (10 mL) every 4-6 hours
 Children 6 to under 12 years of age 1 teaspoonful (5 mL) every 4-6 hours
 Children under 6 years of age ask a doctor

Other information

STORAGE AND HANDLING SECTION

• 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

INACTIVE INGREDIENT SECTION

citric acid, flavor, methylparaben, potassium citrate, propylene glycol, propylparaben, purified water, sorbitol, sucralose.

Questions & Comments?

OTC - QUESTIONS SECTION

call weekdays from 8 AM to 4 PM AST at 1.787.608.0882.

SPL UNCLASSIFIED SECTION

Contains the same active ingredients as Conex® Pediatric*

Alcohol FREE

Dye FREE

Sugar FREE

Cherry Flavor

ActiPharma
COMMITTED TO HEALTH AND WELL-BEING
WWW.ACTIPHARMA.NET

Manufactured in the USA with imported ingredients for ActiPharma, LLC. San Juan, PR 00917. *Conex® is a registered trademark of Llorens Pharmaceutical Corp. This product is not manufactured, distributed or marketed by Llorens Pharmaceutical Corp.

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ACTICON PEDIATRICACTICON PEDIATRIC

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1299143dexbrompheniramine maleate 1 MG / pseudoephedrine HCl 30 MG in 5 mL Oral SolutionPSN1
1299143dexbrompheniramine maleate 0.2 MG/ML / pseudoephedrine hydrochloride 6 MG/ML Oral SolutionSCD1
1299143dexbrompheniramine maleate 1 MG / pseudoephedrine hydrochloride 30 MG per 5 ML Oral SolutionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
PSEUDOEPHEDRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63102-109-16ACTICON PEDIATRIC473 mL in 1 BOTTLESOLUTION4731

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63102-109-16ML - Milliliter63102-109186a487a-f1b1-440d-a1d5-6aa3d900dabe12025-09-12

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63102-10963102-109-16

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ACTICON PEDIATRICDEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDEACTIPHARMA, LLC3052cc67-e6c0-4d3f-9ec9-ffe58d9fae232025-07-17WarningsExact identifier
ndc (package): 63102-109-16
ndc (product): 63102-109
ndc11 (package): 63102010916
spl id: 72bd27ec-46f9-460c-a600-da5eb8dcd3b0
spl set id: 3052cc67-e6c0-4d3f-9ec9-ffe58d9fae23

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.