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| Product NDC Code | 45737-208 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Biocotron-d |
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| Type | Brand | ||||||
| Pharm Class | Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC] |
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| Active Ingredients |
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| Route | ORAL | ||||||
| Dosage Form | SUSPENSION/ DROPS | ||||||
| RxCUI drug identifier | 1486140 | ||||||
| Application Number | part341 | ||||||
| Labeler Name | Advanced Generic Corporation | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients (in each 5mL) Purpose Dextromethorphan HBr, 10 mg ................................. Cough Suppressant Guaifenesin, 200 mg ................................................ Expectorant Phenylephrine HCl, 5 mg ...................................... Nasal Decongestant
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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
| 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
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients: Carboxymethyl cellulose sodium, Cellulose, Citric Acid, Flavor, Propylene Glycol, Sodium Benzoate, Sodium Saccharin, Water
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.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
Purpose
Information about the drug product’s indications for use.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.
Spl product data elements
Usually a list of ingredients in a drug product.Biocotron-D Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl CITRIC ACID MONOHYDRATE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE CARBOXYMETHYLCELLULOSE SODIUM POWDERED CELLULOSE SODIUM BENZOATE PROPYLENE GLYCOL SACCHARIN SODIUM WATER Cherry Flavor
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.biocotron
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.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.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of the reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? 1-305-403-3788
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API