Active ingredientDextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
Label structure8 sections
Indications and 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 loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive nasal congestion reduces swelling of nasal passages
Dosage and administration
Do not exceed recommended dosage. Adults and Children 12 years of age and older: 2 teaspoonfuls (10mL) every 6 hours, not to exceed 4 doses in a 24 hour period. Children 6 to under 12 years of age: 1 teaspoonful (5 mL) every 6 hours, not to exceed 4 doses in a 24 hour period. Children under 6 years of age: Not recommended for use.
Active ingredients Purpose (in each 5 mL teaspoonful) Dextromethorphan Hydrobromide 20 mg...... Antitussive Guaifenesin 200 mg................................ Expectorant Phenylephrine Hydrochloride 10 mg..........Decongestant
Uses
INDICATIONS & USAGE SECTION
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 loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
nasal congestion
reduces swelling of nasal passages
Warnings
WARNINGS SECTION
Do not exceed recommended dosage.
Do not use this product
OTC - DO NOT USE SECTION
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
OTC - ASK DOCTOR SECTION
a cough that lasts or is chronic such as occurs with smoking, asthma 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
OTC - STOP USE SECTION
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. These could be signs of a serious condition.
new symptoms occur
If pregnant or breast-feeding,
OTC - PREGNANCY OR BREAST FEEDING SECTION
ask a health professional before use.
Keep out of reach of children.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.
Directions
DOSAGE & ADMINISTRATION SECTION
Do not exceed recommended dosage.
Adults and Children 12 years of age and older:
2 teaspoonfuls (10mL) every 6 hours, not to exceed 4 doses in a 24 hour period.
Children 6 to under 12 years of age:
1 teaspoonful (5 mL) every 6 hours, not to exceed 4 doses in a 24 hour period.
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) portalpharmaceutical@gmail.com Manufactured for: Portal Pharmaceutical Mayaguez, PR 00680
Rev. 10/09
PRODUCT PACKAGING:
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
The packaging below represents the labeling currently used:
Principal Display Panel and Side Panel for 118mL Label:
NDC 49963-913-04
Brontuss DX
Antitussive / Expectorant Decongestant
Each teaspoonful (5 mL) for oral administration contains: Dextromethorphan HBr.............. 20 mg Guaifenesin.............................200 mg Phenylephrine HCl.................... 10 mg
Dye Free - Sugar Free Alcohol Free - Gluten Free
4 oz. (118 mL)
Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.
Supplied in a tight, light-resistant container with a child-resistant cap.
Principal Display Panel and Side Panel for 15 mL Label:
NDC 49963-913-15
Brontuss DX
Antitussive / Expectorant Decongestant
Each teaspoonful (5 mL) for oral administration contains: Dextromethorphan HBr.......... 20 mg Guaifenesin........................ 200 mg Phenylephrine HCl................ 10 mg
Dye Free / Sugar Free Alcohol Free / Gluten Free
15 mL (1/2 fl oz)
Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing. Supplied in a tight, light-resistant container with a child-resistant cap. Professional Sample: Not For Sale
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