Search by Drug Name or NDC
NDC 54859-0802-04 Conex 1; 30 mg/5mL; mg/5mL Details
Conex 1; 30 mg/5mL; mg/5mL
Conex is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Llorens Pharmaceutical International Division. The primary component is DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Brompheniramine relieves red, irritated, itchy, watery eyes; sneezing; and runny nose caused by allergies, hay fever, and the common cold. Brompheniramine helps control symptoms, but does not treat the cause of the symptoms or speed recovery. Brompheniramine should not be used to cause sleepiness in children. Brompheniramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.
Related Packages: 54859-0802-04Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Brompheniramine
Product Information
| NDC | 54859-0802 |
|---|---|
| Product ID | 54859-802_0b13510e-96ea-481c-9013-ff68716ac472 |
| Associated GPIs | 43993002542020 |
| GCN Sequence Number | 083105 |
| GCN Sequence Number Description | dexbrompheniramine/pseudoephed SOLUTION 2MG-60MG/5 ORAL |
| HIC3 | Z2N |
| HIC3 Description | 1ST GEN ANTIHISTAMINE AND DECONGESTANT COMBINATION |
| GCN | 51977 |
| HICL Sequence Number | 000507 |
| HICL Sequence Number Description | DEXBROMPHENIRAMINE MALEATE/PSEUDOEPHEDRINE HCL |
| Brand/Generic | Generic |
| Proprietary Name | Conex |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Dexbrompheniramine Maleate, Pseudoephedrine |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LIQUID |
| Route | ORAL |
| Active Ingredient Strength | 1; 30 |
| Active Ingredient Units | mg/5mL; mg/5mL |
| Substance Name | DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE |
| Labeler Name | Llorens Pharmaceutical International Division |
| Pharmaceutical Class | Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 54859-0802-04 (54859080204)
| NDC Package Code | 54859-802-04 |
|---|---|
| Billing NDC | 54859080204 |
| Package | 118 mL in 1 BOTTLE (54859-802-04) |
| Marketing Start Date | 2007-11-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL c564e4f2-7d11-4f3e-aff2-35755fbe7d55 Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Uses:
- Temporarily relieves nasal congestion due to common cold, hay fever or other upper respiratory allergies
- Helps decongest sinus openings and sinus passages
- Reduces swelling of nasal passages, shrinks swollen membranes, and temporarily restores freer breathing through the nose
- Temporarily alleviates the following symtoms due to hay fever (allergic rhinitis) : runny nose, sneezing, itching of the nose or throat, itchy and watery eyes.
SPL UNCLASSIFIED 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.
SPL UNCLASSIFIED SECTION
Ask a doctor before use if you are taking sedatives or tranquilizers.
Ask a doctor before use if you have
- heart disease
- high blood pressure
- thyroid disese
- diabetes
- glucoma
- difficulty in urination due to the enlargement of the prostate gland.
- do not exceed the recommended dosage
- excitability may occur, especially in children
- drowsiness may occur
- avoid alcoholic beverages
- alcohol, sedatives and tranquilizers may increase drowsiness
- use caution when driving a motor vehicle or operating machinery
- nervousness, dizziness or sleeplessness occur
- symptoms do not improve within 7 days or occur with a fever.
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Directions: Do not exceed more than 4 doses in any 24-hour period or as directed by a doctor.
| Age | Dose |
| 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 |
SPL UNCLASSIFIED SECTION
Other Information:
- Store at controlled room temperature 20-25 degree celcius ( 68-77 degree farenheit); excursions permitted to 15-30 degree clecius (59-86 degree farenheit) (See USP Controlled Room Temperture) Tamper evident by imprinted heat seal under cap
- Do not use if there is evidence of tampering
-
WARNING: Phenylketonuric: Contains 13.5 mg of Phenylalanine per 5 mL (one teaspoonful) dose.
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
| CONEX
dexbrompheniramine maleate, pseudoephedrine liquid |
||||||||||||||||||||||
|
||||||||||||||||||||||
|
||||||||||||||||||||||
|
||||||||||||||||||||||
|
||||||||||||||||||||||
|
||||||||||||||||||||||
|
||||||||||||||||||||||
| Labeler - Llorens Pharmaceutical International Division (037342305) |
Revised: 12/2020
Document Id: 0b13510e-96ea-481c-9013-ff68716ac472
Set id: c564e4f2-7d11-4f3e-aff2-35755fbe7d55
Version: 3
Effective Time: 20201223