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NDC 00485-0208-16 ED BRON GP 100; 5 mg/5mL; mg/5mL Details
ED BRON GP 100; 5 mg/5mL; mg/5mL
ED BRON GP is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by EDWARDS PHARMACEUTICALS, INC.. The primary component is GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Guaifenesin is used to relieve chest congestion. Guaifenesin may help control symptoms but does not treat the cause of symptoms or speed recovery. Guaifenesin is in a class of medications called expectorants. It works by thinning the mucus in the air passages to make it easier to cough up the mucus and clear the airways.
Related Packages: 00485-0208-16Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Guaifenesin
Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Phenylephrine is in a class of medications called nasal decongestants. It works by reducing swelling of the blood vessels in the nasal passages.
Related Packages: 00485-0208-16Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 00485-0208 |
|---|---|
| Product ID | 0485-0208_43f06e29-011d-4c45-96a2-c15fa4d90bac |
| Associated GPIs | 43996202100920 |
| GCN Sequence Number | 000702 |
| GCN Sequence Number Description | guaifenesin/phenylephrine HCl LIQUID 100-5 MG/5 ORAL |
| HIC3 | B4W |
| HIC3 Description | DECONGESTANT-EXPECTORANT COMBINATIONS |
| GCN | 54250 |
| HICL Sequence Number | 000250 |
| HICL Sequence Number Description | GUAIFENESIN/PHENYLEPHRINE HCL |
| Brand/Generic | Generic |
| Proprietary Name | ED BRON GP |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | GUAIFENESIN and PHENYLEPHRINE |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LIQUID |
| Route | ORAL |
| Active Ingredient Strength | 100; 5 |
| Active Ingredient Units | mg/5mL; mg/5mL |
| Substance Name | GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE |
| Labeler Name | EDWARDS PHARMACEUTICALS, INC. |
| Pharmaceutical Class | Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-1 Adrenergic Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 00485-0208-16 (00485020816)
| NDC Package Code | 0485-0208-16 |
|---|---|
| Billing NDC | 00485020816 |
| Package | 473 mL in 1 BOTTLE, PLASTIC (0485-0208-16) |
| Marketing Start Date | 2012-06-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL b1fca5aa-d877-45e0-b074-dcbc6af94ee3 Details
SPL UNCLASSIFIED SECTION
Uses
temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other respiratory allergies:
- runny nose
- sneezing
- itching of the nose or throat
- itchy, watery eyes
- nasal congestion
- reduces swelling of nasal passages
- helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
Warnings
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.
Do not take this product, unless directed by a doctor, if you have
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- difficulty in urination due to enlargement of the prostate gland
Do not take this product for persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.
Directions
Do not exceed recommended dosage.
| Adults and children 12 years of age and over: | 2 teaspoonfuls (10 mL) every 4 hours, not to exceed 12 teaspoonfuls in 24 hours, or as directed by a doctor. |
| Children 6 to under 12 years of age: | 1 teaspoonful (5 mL) every 4 hours, not to exceed 6 teaspoonfuls in 24 hours, or as directed by a doctor. |
| Children under 6 years of age: | Consult a doctor. |
Inactive ingredients
PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
ED Bron GP Liquid
E
NDC 0485-0208-16
ED Bron GP
Liquid
Expectorant • Nasal Decongestant
Sugar Free • Alcohol Free • Dye Free
Each teaspoonful (5 mL)
for oral administration contains:
Guaifenesin 100 mg
Phenylephrine HCl 5 mg
Orange Flavor
Tamper evident by foil seal under cap.
Do not use if foil seal is broken or
missing.
Manufactured for:
EDWARDS
Pharmaceuticals, Inc.
Ripley, MS 38663
16oz. (473 mL)
INGREDIENTS AND APPEARANCE
| ED BRON GP
guaifenesin and phenylephrine liquid |
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| Labeler - EDWARDS PHARMACEUTICALS, INC. (195118880) |