FDA Label for Bio-g-tuss Pediatric Drops
View Indications, Usage & Precautions
Bio-g-tuss Pediatric Drops Product Label
The following document was submitted to the FDA by the labeler of this product Advanced Generic Corporation. 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.
Active Ingredients
Dextromethorphan HBr
Guaifenesin
Phenylephrine HCl
Purpose
Cough Suppressant
Expectorant
Nasal Decongestant
Uses
- helps lossen phlegm (mucus) and thin bronchial secretions to drain broncial tubes and make coughs more productive
- temporarily relieves nasal congestion due to hay fever or other respiratory allergies (allergic rhinitis) and cough due to minor throat and bronchial irritation as may occur with the common cold
Warnings
Do not exceed recommended dosage
- If nervousness dizziness, or sleeplessness ocurs, discontinue use and consult a doctor
- If symptoms do not improve wihtin 7 days or are accompanied by fever, consult a doctor.
- for persistant or chronic cough such as occurs with asthma, or if cough is accompanied by excessive phlegm (mucus), unless directed by a doctor
- in a child who is taking a prescription Monoaminooxidase Inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for two 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.
- Do not give this product to a child who has heart disease, high blood pressure, thyroid disease, or diabetes, unless directed by a doctor.
- A persistent cough may be a sign of a serious condition
- if cough persists for more than onweek, tend to recur, or is accompanied by fever, rash or persistent headache, consult a doctor.
Do not use this product
Stop use and ask a doctor
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
| Age | Dose |
| children 6 to under 12 years of age | 2 mL every 6-8 hours |
| chidren 2 to under 6 years of age | 1 mL every 6-8 hours |
| children under 2 years of age | consult a doctor |
Inactive Ingredients
citric acid, grape flavor, glycerin, methylparaben, polyethylene glycol, propylparaben, purified water, sodium citrate, sucralose.
Questions Or Comments
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