FDA Label for G-tron Ped
View Indications, Usage & Precautions
G-tron Ped 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 (in each 5 mL tsp) Purpose
Dextromethorphan HBr, 15 mg............................Cough Suppressant
Guaifenesin, 350 mg..............................................Expectorant
Phenylephrine HCl, 10 mg................................Nasal decongestant
Otc - Purpose
Uses
- suppresses cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passages of bothersome mucus, drain bronchial tubes, and make coughs more productive
- temporarily relieves nasal congestion due to a cold
Warnings
Warnings
Do not use 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.
Otc - Do Not Use
Ask a doctor before use if you have
- diabetes
- heart disease
- thyroid disease
- high blood pressure
- trouble urinating due to an enlarged prostate gland
- cough that occurs with too much phlegm (mucus)
- cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema.
- you get nervous, dizzy or sleepless
- symptoms do not get better within 7 days or are accompanied by fever
- cough last more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. These could be a signs of a serious condition.
When using this product do not use more than directed.
Stop use and ask a doctor if
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 accidental overdose, get medical help or contact a Poison Control Center right away.
Directions
do not take more than 6 doses in any 24-hour period
EVERY 4 HOURS
- Adults and Children 12 years of age and older: 5 mL (1 tsp)
- Children 6 to under 12 years of age: (2.5 mL (1/2 tsp)
- Children under 6 years of age: Consult physician
Indications & Usage
Other information
Tamper Evident Feature: Do not use if inner seal is torn, broken or missing.
Store at controlled room temperature 15-30°C (59-86°F).
Avoid excessive heat and humidity.
Inactive Ingredient
Inactive ingredients Citric acid, flavor, hydroxyethyl cellulose, methyl paraben, potassium citrate, polyethylene glycol, propyl paraben, purified water, sorbitol and sucralose.
Otc - Questions
Manufactured in the USA for Kramer-Novis, San Juan, PR 00917.
Tel: (787) 767-2072 / www.kramernovis.com
Principal Display Panel
G-TRON® PED
COUGH SUPPRESSANT
EXPECTORANT
NASAL DECONGESTANT
Contains the same active ingredients as Broncotron® PEDSUGAR FREE
DYE FREE
ALCOHOL FREE
GRAPE FLAVOR
16 Fl. Oz. (474 mL)
KRAMER-NOVIS
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