ACTICON ® COLD & ALLERGY Tablets

Manufacturer
ACTIPHARMA, LLC
Effective date
2025-07-08
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:07:04

Label at a glance#

ProductACTICON
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 upper respiratory allergies: • runny nose • sneezing • itching of the nose or throat • itchy, watery eyes • nasal congestion • reduces swelling of nasal passages

Dosage and administration

Do not exceed recommended dosage. Adults and children 12 years of age and over: 1 tablet every 4 to 6 hours not to exceed 4 tablets in 24 hours or as directed by a doctor Children 6 to under 12 years of age: 1/2 tablet every 4 to 6 hours not to exceed 2 tablets in 24 hours or as directed by a doctor Children under 6 years of age Consult a doctor

Storage and handling

Store at 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].

Label contents#

Full prescribing information#

Active ingredients (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Dexbrompheniramine Maleate, USP 2 mg
Pseudoephedrine HCl, USP 60 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 upper respiratory allergies:
• runny nose • sneezing
• itching of the nose or throat
• itchy, watery eyes
• nasal congestion
• reduces swelling of nasal passages

Warnings

WARNINGS SECTION

Do not exceed recommended dosage.

Do not use
• 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 mellitus
• 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
• 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 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 recommended dosage.

Adults and children 12 years of age and over:1 tablet every 4 to 6 hours not to exceed 4 tablets in 24 hours or as directed by a doctor
Children 6 to under 12 years of age:1/2 tablet every 4 to 6 hours not to exceed 2 tablets in 24 hours or as directed by a doctor
Children under
6 years of age
Consult a doctor

Other information

STORAGE AND HANDLING SECTION

Store at 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].

Inactive ingredients

INACTIVE INGREDIENT SECTION

Magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Questions or Comments?

OTC - QUESTIONS SECTION

call weekdays from 8AM to 4PM AST at 1.787.608.0882

SPL UNCLASSIFIED SECTION

Contains the same active ingredients as Conex® Tablets*

Manufactured in USA with imported ingredients for ActiPharma, LLC. San Juan, PR 00917.  www.actipharma.net

*Conex® Tablets is a registered trademark of Llorens Pharmaceutical Corp. This product is not manufactured, distributed or marketed by Llorens Pharmaceutical Corp.

Tamper evident by foil seal under cap.
Do not use if foil seal is broken or missing. 

Manufactured for:
ActiPharma
COMMITTED TO HEALTH AND WELL-BEING
WWW.ACTIPHARMA.NET
San Juan, PR 00917

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ACTICONACTICON

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1363513dexbrompheniramine maleate 2 MG / pseudoephedrine HCl 60 MG Oral TabletPSN6
1363513dexbrompheniramine maleate 2 MG / pseudoephedrine hydrochloride 60 MG Oral TabletSCD6

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63102-401-602023-10-13C16284748780-10191ceaa-70e3-198a-e063-dbdaa90aec3eACTICON ® COLD & ALLERGY Tablets
63102-401-602023-07-28C16284748780-10191ceaa-70e3-198a-e063-dbdaa90aec3eACTICON ® COLD & ALLERGY Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63102-401-60ACTICON60 in 1 BOTTLE, PLASTICTABLET606

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63102-401-60EA - Each63102-401c2cee2a0-2d2e-46be-9bfa-4e990d78d77f12016-07-19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DEXBROMPHENIRAMINE MALEATEACTIVE INGREDIENTBPA9UT29BS1
PSEUDOEPHEDRINE HYDROCHLORIDEACTIVE INGREDIENT6V9V2RYJ8N1
DEXBROMPHENIRAMINEACTIVE MOIETY75T64B71RP1
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9F1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I301
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A21

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63102-40163102-401-60

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 4 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

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
ACTICONDEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDEACTIPHARMA, LLC847014ab-86ae-40c5-8e7f-f1ddea14f1b32025-07-08WarningsExact identifier
ndc (package): 63102-401-60
ndc (product): 63102-401
ndc11 (package): 63102040160
spl id: fa228895-52c1-44e7-b53c-fad106868c0d
spl set id: 847014ab-86ae-40c5-8e7f-f1ddea14f1b3

Reported adverse events (FAERS/openFDA)#

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