FDA Label for Broncomar Expectorant
View Indications, Usage & Precautions
Broncomar Expectorant Product Label
The following document was submitted to the FDA by the labeler of this product Dannso Corp./d.b.a. Essential Products. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
| Active Ingredients:(in each 10 ml.) | Purpose |
Acetaminophen 250 mg ........................................................ | Analgesic |
Dextromethorphan Hydrobromide 13.33 mg ....................... | Cough Suppressant |
Guaifenesin USP 200 mg...................................................... | Expectorant |
Phenylephrine HCl 5 mg....................................................... | Decongestant |
Otc - Purpose
Uses:
- For temporary relief og Bronchial and Nasal congestion
- Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make cough more productive.
- Temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold.
Warnings
Warnings
Do not exceed recommended dosage
Liver Warning this product contatins Acetaminophen. Severe liver damage may occur if
Otc - Do Not Use
- Adult takes more than 6 doses in 24 hours, which is the maximum daily amount
- Child takes more than 5 doses in 24 hours
- Taken with other drugs containing Acetaminophen.
- Adult has 3 or more alcoholic drinks every day while using this product
- Do not give to children under 3 years of age or use for more than 10 days unless directed by a physician
- Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric conditions, or Parkinson's disease) or for 2 weeks after stopping MAOI drug.
- If you do not know if your prescription drug contains MAOI as your doctor or pharmacist before taking this product.
- If you have a chronic pulmonary disease or shortness of breath unless directed by a doctor.
- Avoid alcoholic beverage while taking this product.
- Do not use with any other drug containing Acetaminophen (prescription no nonprescription) If you are not sure whether a drug contains Acetaminophen, ask a doctor or pharmacist
- Nervousness, dizziness or sleeplessness occurs.
- Cough persists more than 1 week, tends to recur or is accompanied by a fever, rash or persistent headache. A persistent cough may be signserious condition.
Stop use and ask a doctor
Otc - Ask Doctor
Ask doctor before use if you have
- Cough that occurs with too much phlegm(mucus)
- Cough that last or is a chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema.
- Heart disease, high blood pressure, thyroid disease, or difficulty in urination due enlargement of prostate gland.
- The user has Liver diseases
- The user us taking the blood thinning drug Warfarin
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
- Do not exceed 6 doses in any 24-hour period.
| AGE | DOSE |
| Adults and Children 12 years and over | 10 ml (2 tsps) every 6 hours |
| Children 6 to under 12 years of age | 5 ml (1 tsp) every 6 hours |
| Children under 6 years of age | Do not use |
Indications & Usage
Other Information:
- Each 10 mls contains: sodium 4 mg
- Store between 15 - 30 degrees Celsius (59 - 86 Fahrenheit).
- Tamper Evident Feature:Do not use if seal under cap is torn, broken or missing.
Inactive Ingredient
Aloe Vera, Citric Acid, Disodium EDTA, FDC Red #40, Hydroxyethyl Cellulose, Natural Strawberry Flavor, Propylene Glycol USP, Purified Water, Sodium Benzoate, Sorbitol 70% USP, Sucralose.
Questions Or Comments
Call Weekdays from 9:30 AM to 5PM EST at Tel 305-261-762
Distributed by
Essential Products Miami FL 33126
Made in U.S.A.
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