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#
Contacts and useful links#
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
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1299143 | dexbrompheniramine maleate 1 MG / pseudoephedrine HCl 30 MG in 5 mL Oral Solution | PSN | 4 |
| 1299143 | dexbrompheniramine maleate 0.2 MG/ML / pseudoephedrine hydrochloride 6 MG/ML Oral Solution | SCD | 4 |
| 1299143 | dexbrompheniramine maleate 1 MG / pseudoephedrine hydrochloride 30 MG per 5 ML Oral Solution | SY | 4 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| PSEUDOEPHEDRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906 | Product name | 7 | 20210625 |
| ba088a92-ab5e-b2d4-e908-f5ea691b7587 | Product name | 7 | 20210201 |
| 0fdb98e2-b951-a1ce-5715-2b187ba500ef | Product name | 4 | 20170718 |
| e974e22d-8688-7d92-1e87-40c1079e170c | Product name | 3 | 20151125 |
| e8718272-64cb-4436-969b-176c3067c8f4 | Product name | 1 | 20150609 |
| 30c51294-7ae9-8007-7de6-58222684a0be | Product name | 1 | 20140508 |
| 4f26f669-fc6c-40ef-9e26-1c7b2390ee66 | Product name | 1 | 20140508 |
| 70a83adc-6047-bbea-5a08-dfd304aa47d2 | Product name | 1 | 20140508 |
| 858ce051-9941-aafc-8c7c-44a8e0227463 | Product name | 1 | 20140508 |
| b893258d-0942-3d8a-3411-056ea0788ff5 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 45737-239-16 | 2020-12-23 | C162847 | 48780-1 | 9d75b9cf-ff3e-f424-e053-dadaa90a57ce | AGC-BioCNex 239 |
| 45737-239-16 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-ff3e-f424-e053-dadaa90a57ce | AGC-BioCNex 239 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 45737-239-16 | BIO-CNEX | 473 mL in 1 BOTTLE | LIQUID | 473 | 4 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- BIO-CNEX
- Dexbrompheniramine Maleate, Pseudoephedrine HCl
- ASPARTAME
- ANHYDROUS CITRIC ACID
- GLYCERIN
- MENTHOL
- METHYLPARABEN
- POTASSIUM CITRATE
- POTASSIUM SORBATE
- PROPYLENE GLYCOL
- PROPYLPARABEN
- WATER
- DEXBROMPHENIRAMINE MALEATE
- DEXBROMPHENIRAMINE
- PSEUDOEPHEDRINE HYDROCHLORIDE
- PSEUDOEPHEDRINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 45737-239 | 45737-239-16 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ASPARTAME | Z0H242BBR1 | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| MENTHOL | L7T10EIP3A | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| POTASSIUM CITRATE | EE90ONI6FF | IACT |
| POTASSIUM SORBATE | 1VPU26JZZ4 | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| WATER | 059QF0KO0R | IACT |
| DEXBROMPHENIRAMINE MALEATE | BPA9UT29BS | ACTIB |
| PSEUDOEPHEDRINE HYDROCHLORIDE | 6V9V2RYJ8N | ACTIB |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 29bbc1d4-b821-76ea-e063-6294a90a1e7b | 66bc0143-c6ca-42a8-b454-138cdbe07ac2 | 2024-12-20 | Warnings | 29bbc1d4-b821-76ea-e063-6294a90a1e7b 66bc0143-c6ca-42a8-b454-138cdbe07ac2 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
