G-TUSS-NL PED- dextromethorphan hydrobromide, guaifenesin, and pseudoephedrine hydrochloride liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS), Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ), Pseudoephedrine Hydrochloride (UNII: 6V9V2RYJ8N) (Pseudoephedrine - UNII:7CUC9DDI9F)

Available from:

McLaren Medical

INN (International Name):

Dextromethorphan Hydrobromide

Composition:

Dextromethorphan Hydrobromide 5 mg in 5 mL

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

- For the temporary relief of nasal congestion due to the common cold, hay fever or other upper respiratory allergies (allergic rhinitis). - Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive. - Temporarily controls cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants. - Temporarily helps you cough less.

Authorization status:

OTC monograph final

Summary of Product characteristics

G-TUSS-NL PED- DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND
PSEUDOEPHEDRINE
HYDROCHLORIDE LIQUID
MCLAREN MEDICAL
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may be marketed if they_
_comply with applicable regulations and policies. FDA has not
evaluated whether this product complies._
----------
G-TUSS-NL PED
_DRUG FACTS_
_ACTIVE INGREDIENTS (IN EACH 5 ML,_
_TEASPOONFUL)_
_PURPOSE_
Guaifenesin 50 mg
Expectorant
Dextromethorphan HBr 5 mg
Cough Suppressant
Pseudoephedrine HCI 15 mg
Nasal Decongestant
INDICATIONS
For the temporary relief of nasal congestion due to the common cold,
hay fever or other upper
respiratory allergies (allergic rhinitis).
Helps loosen phlegm (mucus) and thin bronchial secretions to make
coughs more productive.
Temporarily controls cough due to minor throat and bronchial
irritation as may occur with the
common cold or inhaled irritants.
Temporarily helps you cough less.
WARNINGS
DO NOT EXCEED RECOMMENDED DOSAGE.
If nervousness, dizziness or sleeplessness occurs, discontinue use and
consult a doctor.
If symptoms do not improve within 7 days or are accompanied by fever,
consult a doctor.
Do not give this product to a child who has heart disease, high blood
pressure, thyroid disease, or
diabetes, unless directed by a doctor.
Do not use in a child who is 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 child's
prescription drug contains an
MAOI, ask a doctor or pharmacist before giving this product.
A persistent cough may be the sign of a serious condition. If cough
persists for more than 1 week,
tends to recur or is accompanied by a fever, rash or persistent
headache, consult a doctor.
Do not take this product for persistent or chronic cough such as
occurs with asthma or emphysema
or if cough is accompanied by excessive phlegm (mucus) unless directed
by a doctor.
IN CASE OF ACCIDENTAL OVE