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| Product NDC Code | 58809-216 | ||||
|---|---|---|---|---|---|
| Drug Name | Texaclear kids daytime 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 | LIQUID | ||||
| RxCUI drug identifier | 2670470 | ||||
| Application Number | M012 | ||||
| Labeler Name | GM Pharmaceuticals, 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 15 mL) Dextromethorphan HBr 5 mg Guaifenesin 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 exceed 6 doses per 24-hour period. measure only with the dosing cup provided. mL= milliliter Age Dose children 6 years to under 12 years 30 mL (2 dose cups) every 4 hours children 4 years to under 6 years 15 mL (1 dose cup) every 4 hours children under 4 years do not use.
| Age | Dose |
|---|---|
| children 6 years to under 12 years | 30 mL (2 dose cups) every 4 hours |
| children 4 years to under 6 years | 15 mL (1 dose cup) every 4 hours |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients citric acid, glycerin, maltitol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol, sucralose
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 helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive. temporarily relieves: the intensity of coughing cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
Purpose
Information about the drug product’s indications for use.Purpose Cough suppressant Expectorant
Spl product data elements
Usually a list of ingredients in a drug product.TexaClear Kids Daytime Cough and Chest Congestion Dextromethorphan HBr, Guaifenesin ANHYDROUS CITRIC ACID GLYCERIN MALTITOL PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM CITRATE SACCHARIN SODIUM SORBITOL SUCRALOSE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN
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.Principal Display Panel TexaClear Kids Daytime Cough and Chest Congestion NDC 58809-216-08 8 fl. oz. (237 mL) Dextromethorphan HBR – Cough Suppressant Guaifenesin – Expectorant Tamper evident: do not use if foil seal under cap is broken on missing Dye Free Sugar Free Gluten Free Alcohol Free Acetaminophen Free Ages 4+ Relieves: Chest Congestion Thins & Loosens Mucus Cough Distributed by: GM Pharmaceuticals, Inc. Fort Worth, TX 76118 PDP Drug Facts
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.TexaClear Kids Daytime Cough and Chest Congestion (dextromethorphan HBr, guaifenesin), solution GM Pharmaceuticals, Inc. Drug Facts
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 persistent or chronic cough such as occurs with asthma a cough that occurs with too much phlegm (mucus) a sodium-restricted diet
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 (MOAI) (certain drugs for depression, pschiatric, 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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information each 15 mL contains: Sodium 7.5 mg store at room temperature 20-30°C (68-86°F)
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? Call 1-888-535-0305 9 a.m. - 5 p.m. CST. Distributed by: GM Pharmaceuticals, Inc. Fort Worth, TX. 76118
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 persistent headache. These could be signs of a serious illness.
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.Do not exceed recommended dosage . Do not use in a child who is taking a prescription monoamine oxidase inhibitor (MOAI) (certain drugs for depression, pschiatric, 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 persistent or chronic cough such as occurs with asthma a cough that occurs with too much phlegm (mucus) a sodium-restricted diet Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
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