BIO-CNEX

Manufacturer
Advanced Generic Corporation
Effective date
2024-12-20
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:47:31

Label at a glance#

ProductBIO-CNEX
Active ingredientDEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each 5 mL tsp.)                 Purpose

Dexbrompheniramine maleate 1 mg                            Antihistamine

Pseudoephedrine Hydrochloride 30 mg                         Nasal Decongestant

OTC - PURPOSE SECTION

Purpose

Antihistamine

Nasal Decongestant

WARNINGS SECTION

Warnings

DO not use If you are 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 you are taking a prescription drug that contains an MAOI, ask your doctor or pharmacist before taking this product.

Ask a doctor before use if you are taking sedative or tranquilizers.

Ask a doctore before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • difficulty in urinations due to the enlargment of the prostate gland.

When using this product

  • Do not exceed the recommended dosage
  • excitability may occur, espicially in children
  • drowsiness may occur
  • avoid alcoholic beverages
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • use cuation 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 occur with fever.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding,ask a Health Professional before use.

DOSAGE & ADMINISTRATION SECTION

Directionsdo not exceed 4 doses in 24 hours.

adults and children
12 years of age and over

take two teaspoonfuls (10 mL)

every 4 to 6 hours

children 6 to under
12 years of age

take one teaspoonful (5 mL)

every 4 to 6 hours

children under 6 years of age

ask a doctor

INDICATIONS & USAGE SECTION

Uses

  • Temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  • helps decongest sinus opening and sinus passages
  • reduces swelling of nasal pasages, shrinks swollen membranes, and temporarily restores freer breathing through the nose
  • temporarily alleviates the following symptoms due to hay fever (allergic rhinitis)
  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy and watery eyes

INACTIVE INGREDIENT SECTION

Inactive ingredients Aspertame, cherry flavor, citric acid, glycerine, menthol, methylparaben, potsassium citrate, potassium sorbate, propylene glycol, propylparaben and purified water.

OTC - QUESTIONS SECTION

Questions or comments?

1-305-403-3788

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

biocnexbiocnex

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1299143dexbrompheniramine maleate 1 MG / pseudoephedrine HCl 30 MG in 5 mL Oral SolutionPSN4
1299143dexbrompheniramine maleate 0.2 MG/ML / pseudoephedrine hydrochloride 6 MG/ML Oral SolutionSCD4
1299143dexbrompheniramine maleate 1 MG / pseudoephedrine hydrochloride 30 MG per 5 ML Oral SolutionSY4

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
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
45737-239-162020-12-23C16284748780-19d75b9cf-ff3e-f424-e053-dadaa90a57ceAGC-BioCNex 239
45737-239-162020-01-31C16284748780-19d75b9cf-ff3e-f424-e053-dadaa90a57ceAGC-BioCNex 239

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45737-239-16BIO-CNEX473 mL in 1 BOTTLELIQUID4734

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45737-239BIO-CNEX (DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCL) LIQUID [ADVANCED GENERIC CORPORATION]4Legacy NDC, 1 package rows20241222_66bc0143-c6ca-42a8-b454-138cdbe07ac2.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
45737-23945737-239-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 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
29bbc1d4-b821-76ea-e063-6294a90a1e7b66bc0143-c6ca-42a8-b454-138cdbe07ac22024-12-20WarningsExact identifier
spl id: 29bbc1d4-b821-76ea-e063-6294a90a1e7b
spl set id: 66bc0143-c6ca-42a8-b454-138cdbe07ac2

Reported adverse events (FAERS/openFDA)#

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