FDA Label for Brontuss Sf-nr
View Indications, Usage & Precautions
Brontuss Sf-nr Product Label
The following document was submitted to the FDA by the labeler of this product Portal Pharmaceutical. 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.
Drug Facts
Active ingredients(in each 5 mL teaspoonful)Dextromethorphan Hydrobromide 15 mgGuaifenesin 300 mgPhenylephrine Hydrochloride 10 mg
Purpose
AntitussiveExpectorantNasal Decongestant
Uses
Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:
- cough due to minor throat and bronchial irritation
- helps phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
- nasal congestion
- reduces swelling of nasal passages
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.
Ask A Doctor Before Use If You Have
- a cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
- a cough that occurs with too much phlegm (mucus)
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
Stop Use And Ask A Doctor If
- nervousness, dizziness, or sleeplessness occur
- cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
Do not exceed recommended dosage.
| Adults and Children 12 years of age and over: | 1 teaspoonful (5 mL) every 4 hours, not to exceed 6 doses in 24 hours. |
| Children 6 to under 12 years of age: | 1/2 teaspoonful (2.5 mL) every 4 hours, not to exceed 6 doses in 24 hours. |
| Children under 6 years of age: | Consult a doctor. |
Other Information
- Each 5 mL teaspoonful contains 5 mg sodium.
- Store at 59°-86° F (15°-30° C)
Inactive Ingredients
Citric acid, glycerin, grape flavor, propylene glycol, purified water, sodium citrate, sodium saccharin, sorbitol.
Questions? Comments?
Call your doctor for medical advice about side effects. Serious side effects associated with this product may be reported to this number.Call (787) 832-6645. Operation Hours: Monday - Friday, 8 A.M. to 4 P.M. Atlantic Standard Time (AST) [email protected] for:Portal PharmaceuticalMayaguez, PR 00681Rev. 11/11
Product Packaging
The packaging below represents the labeling currently used.Principal display panel and side panel for 30 mL label:NDC 49963-381-01BrontussSF-NRLiquid· Antitussive · Expectorant· Nasal DecongestantEach teaspoonful (5 mL) fororal administration contains:Dextromethorphan HBr....................15 mgGuaifenesin..................................300 mgPhenylephrine HCl..........................10 mgGrape FlavorDye Free · Sugar Free · Alcohol Free1 oz. (30 mL)Tamper evident by foil seal under cap. Do not use iffoil seal is broken or missing.Supplied in a tight, light-resistant container with a child-resistant cap.Manufactured for:PORTALPharmaceuticalMayaguez, PR 00680 Rev. 11/11Professional Sample: Not For Sale
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