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Bio-z-cough - Medication Information

Product NDC Code 45737-251
Drug Name

Bio-z-cough

Type Brand
Pharm Class Sigma-1 Agonist [EPC],
Sigma-1 Receptor Agonists [MoA],
Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],
Uncompetitive NMDA Receptor Antagonists [MoA]
Active Ingredients
Dextromethorphan hydrobromide 20 mg/5ml
Guaifenesin 400 mg/5ml
Route ORAL
Dosage Form LIQUID
RxCUI drug identifier 1113368
Application Number part341
Labeler Name Advanced Generic Corporation
Packages
Package NDC Code Description
45737-251-16 473 ml in 1 bottle (45737-251-16)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredients (in each 5 mL tps.) Purpose Dextromethorphan Hydrobromide.... 20 mg...........................Cough suppressant Guaifenesin.... 400 mg........................................................Expectorant

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.
Direction: do not exceed more than 6 doses in any 24 hours period. Adults and children 12 years of age and over. Take 1 teaspoonful (5 mL) every 4 hours Children under 12 years of age. Consult a physician
Adults and children 12 years of age and over. Take 1 teaspoonful (5 mL) every 4 hours
Children under 12 years of age. Consult a physician

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients: Citric Acid, eucalyptus oil, menthol, methylparaben, propylparaben, propylene glycol, sodium citrate, polyethylene glycol, grape flavor, sucralose, and purified 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 celsius (59 - 86 degrees farenheit) Tamper evident feature Do not use if seal under cap is torn, broken or missing. Avoid excessive heat or humidity.

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 a cold.

Spl product data elements

Usually a list of ingredients in a drug product.
Bio-Z-Cough Dextromethorphan Hydrobromide, Guaifenesin DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN CITRIC ACID MONOHYDRATE EUCALYPTUS OIL MENTHOL METHYLPARABEN PROPYLPARABEN POLYETHYLENE GLYCOL, UNSPECIFIED SUCRALOSE WATER PROPYLENE GLYCOL SODIUM CITRATE grape 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.
biozcof label

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 of 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 MAOI; ask your doctor or pharmacist before taking this product.

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 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 Manufactured for: Advanced Generic Corporation Miami, FL 33166 www.advancedgeneric.com

Pregnancy or breast feeding

Pregnancy or Breast feeding
If 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: cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema. When using this product do not use more than directed. Stop use and ask a doctor before use if: 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.

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