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Product NDC Code | 11822-5050 | ||||
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Drug Name | Mucus dm |
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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 | M012 | ||||
Labeler Name | Rite Aid Corporation | ||||
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 any other device keep dosing cup with product mL = milliliter dose as follows or as directed by a doctor adults and children 12 years of age and 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, disodium EDTA, FD&C red #40, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, 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.Uses helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common 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.Mucus DM Dextromethorphan Hydrobromide Guaifenesin DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN ANHYDROUS CITRIC ACID EDETATE DISODIUM FD&C RED NO. 40 GLYCERIN PROPYL GALLATE PROPYLENE GLYCOL WATER SODIUM BENZOATE TRISODIUM CITRATE DIHYDRATE 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.Principal Display Panel *Compare to the active ingredients in Maximum Strength Mucinex® Fast-Max® DM Max MAXIMUM STRENGTH mucus relief DM max dextromethorphan HBr 20 mg guaifenesin 400 mg cough suppressant expectorant controls cough relieves chest congestion thin & loosens mucus 4 hour dosing for ages 12+ *This product is not manufactured or distributed by Reckitt Benckiser, distributor of Maximum Strength Mucinex® Fast-Max® DM Max TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. DISTRIBUTED BY: RITE AID 30 HUNTER LANE CAMP HILL, PA 17011 Questions or comments? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Package Label RITE AID Maximum Strength Mucus Relief DM Max Dextromethorphan HBr 20 mg, Guaifenesin 400 mg
Ask doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.Ask a doctor before use if you have persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough accompanied by 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 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 (1-800-222-1222) 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 20 mL contains: sodium 20 mg store between 20-25°C (68-77°F). Do not refrigerate.
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 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.
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 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. Ask a doctor before use if you have persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough accompanied by too much phlegm (mucus) When using this product, do not use more than directed. 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 condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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