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Product NDC Code | 59800-1365 | ||||
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Drug Name | Muca clear |
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Type | Brand | ||||
Pharm Class | Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE] |
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Active Ingredients |
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Route | ORAL | ||||
Dosage Form | TABLET | ||||
RxCUI drug identifier | 197741 | ||||
Application Number | M012 | ||||
Labeler Name | Schwabe North America, Inc | ||||
Packages |
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Overdosage of Muca Clear
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.Overdosage In case of overdose, seek medical help or contact a Poison Control Center immediately.
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Guaifenesin 200 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.Dosage & Administration Adults & children 12 years of age and older: Take 1-2 tablets every 4 hours, not to exceed 12 tablets in 24 hours. Children 6 - 11 years of age: Take ½ - 1 tablet every 4 hours not to exceed 6 tablets in 24 hours. Children under 6 years of age: Consult a doctor before use. Purpose Helps loosen phlegm (mucus) and thin bronchial secretions to rid bronchial passageways of mucus and make coughs more productive. Indications & Usage Helps loosen phlegm (mucus) and thin bronchial secretions to rid bronchial passageways of mucus and make coughs more productive.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredient carnauba wax cellulose dextrin fenugreek (Trigonella foenum-graecum) (seed) extract glycerin hypromellose magnesium stearate maltodextrin marshmallow (Althaea officinalis) (root) extract mullein (Verbascum thapsus) (leaf) extract povidone silica sodium croscarmellose stearic acid
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.Indications & Usage Helps loosen phlegm (mucus) and thin bronchial secretions to rid bronchial passageways of mucus and make coughs more productive.
Purpose
Information about the drug product’s indications for use.Purpose Helps loosen phlegm (mucus) and thin bronchial secretions to rid bronchial passageways of mucus and make coughs more productive.
Spl product data elements
Usually a list of ingredients in a drug product.Muca Clear GUAIFENESIN CARNAUBA WAX MICROCRYSTALLINE CELLULOSE ICODEXTRIN FENUGREEK SEED GLYCERIN MAGNESIUM STEARATE MALTODEXTRIN ALTHAEA OFFICINALIS ROOT HYPROMELLOSE, UNSPECIFIED CROSCARMELLOSE SODIUM MULLEIN LEAF POVIDONE SILICON DIOXIDE STEARIC ACID GUAIFENESIN GUAIFENESIN pale yellow to brown with specks Convex face, debossed 232 tablet 232
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.Add image transcription here... LZP13653.H02-Muca-Clear-(OTC)-100-tabs.jpg
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 Doctor Ask a doctor before use if you have a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, a cough that is accompanied by excessive phlegm (mucus), diabetes, been taking any medications.
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 Keep out of reach of children.
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 Stop use and ask a doctor if cough persists more than one week, tends to recur, or is accompanied by a fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
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 this product if you are pregnant, attempting to be pregant, or breast-feeding. Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.
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