FDA Label for Biocotron-d
View Indications, Usage & Precautions
Biocotron-d 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, 10 mg ................................. Cough Suppressant
Guaifenesin, 200 mg ................................................ Expectorant
Phenylephrine HCl, 5 mg ...................................... Nasal Decongestant
Otc - Purpose
Uses
Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes. Temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold. Temporarily relieves nasal congestion due to the common cold.
Warnings
Warnings:
Ask a doctor before use if you have:Heart disease, high blood pressure, thyroid disease, diabetes, trouble urinating due to an enlarged prostate gland, cough that last or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema.
Ask doctor or pharmacist before use if you are taking any other nasal decongestant or stimulant.
When using this product do not use more than directed.
Otc - Do Not Use
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 you are taking a prescription drug that contains an MAOI, ask a doctor or pharmacist before taking this product.
Stop use and ask a doctor before use if:
- you get nervous, dizzy or sleepless; symptoms do not get better within 7 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.
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.
Dosage & Administration
Directions: Do not take more than 3 doses in any 24-hour period.
| Age | Dose |
| Adults and children 12 years of age and over | 2 teaspoons every 4 hours |
| Children 6 to under 12 years of age | 1 teaspoon every 4 hours |
| Children 2 to under 6 years of age | 1/2 teaspoon every 4 hours |
| Children under 2 years of age | Ask a doctor |
Inactive Ingredient
Inactive ingredients: Carboxymethyl cellulose sodium, Cellulose, Citric Acid, Flavor, Propylene Glycol, Sodium Benzoate, Sodium Saccharin, Water
Otc - Questions
Questions or comments? 1-305-403-3788
Indications & Usage
Other information:Store at room temperature 15-30 degrees C (59-86 degrees F)
Tamper evident:Do not use if seal under cap (or cello-band over cap) is torn, broken or missing.
Each teaspoonful (5mL) contains:Sodium 6 mg
Package Label.Principal Display Panel
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding,ask a health professional before use.
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