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| Product NDC Code | 83324-026 | ||||
|---|---|---|---|---|---|
| Drug Name | Qch maximum strength mucus relief dm 628 |
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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 | 1020138 | ||||
| Application Number | part341 | ||||
| Labeler Name | Chain Drug Marketing Association Inc. | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENTS (in each 20 mL) Dextromethorphan HBr, 20 mg Guaifenesin, 400 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 take more than 6 doses in any 24-hour period measure only with dosing cup provided do not use dosing cup with other products dose as follows or as directed by a doctor Adults & children 12 years & older: 20 mL every 4 hours Children under 12 years of age: Do not use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS citric acid anhydrous, dextrose, D&C red # 33, FD&C Red #40, flavors, glycerin, methylparaben, potassium sorbate, propylene glycol, propylparaben, purified water, saccharin sodium, sodium hydroxide, sorbitol, sucralose, xanthan gum.
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.USE(S) helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive temporarily relieves: cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants the intensity of coughing the impulse to cough to help you get to sleep
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.QCH Maximum Strength Mucus Relief DM 628 Dextromethorphan HBr, Guaifenesin DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN ANHYDROUS CITRIC ACID D&C RED NO. 33 DEXTROSE, UNSPECIFIED FORM FD&C RED NO. 40 GLYCERIN METHYLPARABEN POTASSIUM SORBATE PROPYLENE GLYCOL PROPYLPARABEN WATER SACCHARIN SODIUM SODIUM HYDROXIDE SORBITOL SUCRALOSE XANTHAN GUM
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.PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 83324-026-06 QUALITY CHOICE ® *Compare to the Active Ingredient Maximum Strength Mucinex Fast Max DM ® Maximum Strength Mucus Relief Cough Suppressant / Expectorant Dextromethorphan HBr, 20 mg Per 20 mL Guaifenesin, 400 mg Per 20 mL Helps Control Cough Relieves Chest Congestion Thins and Loosens Mucus Cherry Flavor 6 FL OZ (177 mL) 628-front-qch 628-back-qch
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 persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema cough that occurs with too much phlegm (mucus)
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 for children under 12 years of age 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 your prescription drug contains an MAOI, ask a 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 REACH OF CHILDREN In case of overdose, get medical help or contact a Poison Control Center right away.
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 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 condition.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.WHEN USING THIS PRODUCT do not use more than directed
Pregnancy or breast feeding
Pregnancy or Breast feedingIF PREGNANT OR BREAST-FEEDING ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.OTHER INFORMATION each 20 mL contains: potassium 20 mg, sodium 20 mg store between 15-30°C (59-86°F) do not refrigerate dosing cup provided
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 .
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