FDA Label for Tussi Pres

View Indications, Usage & Precautions

Tussi Pres Product Label

The following document was submitted to the FDA by the labeler of this product Kramer Novis. 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 per 5 ml: Guaifenesin 200 mg, Phenylephrine HCL 5 mg, Dextromethorphan HBr 10 mg


Otc - Purpose



COUGH SUPPRESSANT

NASAL DECONGESTANT

EXPECTORANT


Indications & Usage



Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

temporarily relieves these symptoms occurring with cold:

nasal congestion

cough due to minor throat and bronchial irritation


Warnings



Do Not Use: in a child under 2 years of age

if you are 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 heart disease, thyroid disease, high blood pressure, diabetes

trouble urinating due to enlargement of the prostate gland

cough that occurs with too much phlegm (mucus)

chronic bronchitis or emphysema

When using this product, do not exceed recommended dosage

Stop use and ask a doctor if

you get nervous, dizzy, or sleepless

symptoms do not get better within 7 days or are accompanied by fever

cough lasts more than 7 days, comes back, or is accompanied by fever,

rash, or persistent headache. These could be signs of a serious condition


Dosage & Administration



adults and children 12 years and over 10mL (2 tsp) every 4 hours

children 6 to under 12 years 5mL (1 tsp) every 4 hours

children 2 to under 6 years 2.5mL (1/2 tsp) every 4 hours

under 2 years do not use

do not take more than 6 doses in any 4 hour period


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


Inactive Ingredient



Inactive Ingredients:

citric acid,red 40,glycerin,methylparaben,potassium sorbate,propylene glycol,propylparaben,purified water,sodium citrate,sucralose


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