FDA Label for Biocotron Ped
View Indications, Usage & Precautions
Biocotron Ped 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.
Otc - Active Ingredient
Active Ingredients (in each 5mL) Purpose
Dextromethorphan HBr, 15 mg ................................. Cough Suppressant
Guaifenesin, 350 mg ................................................ Expectorant
Phenylephrine HCl, 10 mg ...................................... Nasal Decongestant
Otc - Purpose
Purpose
Cough Suppressant
Expectorant
Nasal Decongestant
Indications & Usage
Uses
- non-narcotic cough suppressant which temporarily calms cough due to minor throat and bronchial irritation as may occur with the common cold
- calms the cough control center and relieves coughing
- helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive.
- temporarily relieves nasal congestion due to the common cold
- helps decongest sinus openings and passages; temporarily relieves sinus congestion and pressure
Warnings
Warnings:
Do no exceed recommended dosage
a persistent cough may be a sign of a serious condition. If cough persist for more than 1 week, tends to recur, or is accompanied by fever, rash or a persistent headache, constult a doctor
Do not use this product if you
are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional condition. or for two weeks after stopping the MAOI drug. If you do not know if your prescription drug contains a MAOI, ask a doctor or phamacist before taking thie product.
Ask doctor or pharmacist before use if you have
- a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.
- high blood pressure
- heart disease
- thyroid disease
- diabetes
- difficulty in urincation due to enlargment of the prostate gland
- nervousness, dizziness, or sleeplessness occur.
- if symptoms do not improve within 7 days or are accompanied by fever
Stop use and ask a doctor if:
Ask a doctor before use if you are taking sedatives or tranquilizers.
Otc - Keep Out Of Reach Of Children
Keep out of the reach of children.In case of accidental overdose, get medical help or contact a Poison Control Center right away.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a doctor before use.
Dosage & Administration
Directions: Take very 4 hours, not to exceed 6 doses in 24 hours or as directed by physician
| Age | Dose |
| Adults and children 12 years of age or older | 1 teaspoonful (5 mL) every 4 hours |
| Children 6 to under 12 years of age | 1/2 teaspoonful (2.5 mL) every 4 hours |
| Children under 6 years of age | Ask a doctor |
Inactive Ingredient
Inactive ingredients: citric acid, eucalyptus oil, glycerin, hydroxyethyl cellulose, methylparaben, natural and artificial flavor, polyethylene glycol, propylparaben, purified water, sodium citrate, sucralose.
Otc - Questions
Questions or comments? 1-305-403-3788
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