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Kids cough and chest congestion - Medication Information

Product NDC Code 69676-0037
Drug Name

Kids cough and chest congestion

Type Brand
Pharm Class Decreased Respiratory Secretion Viscosity [PE],
Expectorant [EPC],
Increased Respiratory Secretions [PE],
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 5 mg/5ml
Guaifenesin 100 mg/5ml
Route ORAL
Dosage Form SUSPENSION
Application Number M013
Labeler Name Genexa Inc.
Packages
Package NDC Code Description
69676-0037-9 1 bottle, plastic in 1 carton (69676-0037-9) / 118 ml in 1 bottle, plastic
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredients (in each 5 mL) Dextromethorphan HBr, USP 5 mg Guaifenesin, USP 100 mg

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 give more than 6 doses in any 24-hour period use only with enclosed dose cup. Do not use with any other dosing device. mL = milliliter children 6 to under 12 years 5 mL - 10 mL every 4 hours children 4 to under 6 years 2.5 mL - 5 mL every 4 hours children under 4 years do not use
children 6 to under 12 years5 mL - 10 mL every 4 hours
children 4 to under 6 years2.5 mL - 5 mL every 4 hours
children under 4 yearsdo not use

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients organic agave syrup, organic blueberry flavor, natural citrus extract, natural flavor, 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.
Uses temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Purpose

Information about the drug product’s indications for use.
Purposes Cough suppressant Expectorant

Spl product data elements

Usually a list of ingredients in a drug product.
Kids Cough and Chest Congestion Dextromethorphan HBr, Guaifenesin GUAIFENESIN GUAIFENESIN AGAVE TEQUILANA JUICE WATER DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN CITRUS FRUIT BLUEBERRY Golden

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.
Genexa MEDICINE MADE CLEAN Kids' Cough & Chest Congestion Dextromethorphan HB r | Guaifenesin Cough Suppressant - Expectorant Cough Mucus Chest Congestion Medicine made clean Same effective active ingredients, but no artificial fillers. Organic Blueberry Flavor 4 FL OZ (118 mL) Liquid Dosing cup included Kids' Cough & Chest Congestion

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
Drug Facts SHAKE WELL before each use. Bottle is safety sealed with a perforated band around the bottle. DO NOT use if bottle seal is disturbed or missing. Patent Pending | Distributed by: Genexa Inc. Atlanta, GA 30068 | genexa.com Made in the USA with globally sourced ingredients NDC 69676-0037-9

Ask doctor

Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.
Ask a doctor before use if the child has cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with asthma

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 in a child who is 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 your child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving 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 reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions? 1-855-436-3921

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These could be signs of a serious condition.

Storage and handling

Information about safe storage and handling of the drug product.
Other information store between 20-25°C (68-77°F)

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 Do not use in a child who is 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 your child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. Ask a doctor before use if the child has cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with asthma Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These could be signs of a serious condition. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

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