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| Product NDC Code | 69676-0085 | ||||
|---|---|---|---|---|---|
| Drug Name | Kids cough and chest congestion |
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| 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] |
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| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | SOLUTION | ||||
| RxCUI drug identifier | 1020138 | ||||
| Application Number | part341 | ||||
| Labeler Name | Genexa Inc. | ||||
| 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 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 SHAKE WELL BEFORE USING 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 DIRECTIONS Added "SHAKE WELL BEFORE USING" under Directions
| 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 |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients organic agave syrup, organic cherry 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 AGAVE TEQUILANA STEM WATER CITRUS FRUIT GUAIFENESIN GUAIFENESIN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 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 Ages 4-11 Kids' Cough & Chest Congestion Dextromethorphan HB r | Guaifenesin Cough Suppressant - Expectorant Cough Mucus Chest Congestion Made with the same active ingredients as Children’s Robitussin® Cough & Chest Congestion DM* Medicine made clean Same effective active ingredients, but no artificial fillers. Organic Cherry Flavor 4 FL OZ (118 mL) Dosing cup included Kids' Cough and Chest Congestion
Recent major changes
A list of the section(s) that contain substantive changes that have been approved by FDA in the product labeling. The headings and subheadings, if appropriate, affected by the change are listed together with each section’s identifying number and the month and year on which the change was incorporated in the labeling.DIRECTIONS Added "SHAKE WELL BEFORE USING" under Directions
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 *This product is not manufactured or distributed by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC, owner of the registered trademark Children’s Robitussin® Cough & Chest Congestion DM.
Made in the USA with globally sourced ingredients NDC 69676-0085-9
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