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Product NDC Code | 57896-739 | ||||
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Drug Name | Guaiasorb 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 | 996520 | ||||
Application Number | M012 | ||||
Labeler Name | Geri-Care Pharmaceuticals, Corp | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.per 10 mL = 2 teaspoonfuls Dextromethorphan HBr - 20 mg 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.Directions do not exceed recommended dose take every 4 hours as needed, or as directed by a doctor do not take more than 6 doses in 24 hours Adults and children 12 years and over 10 mL (2 teaspoonfuls) Children under 12 years Do not use
Adults and children 12 years and over | 10 mL (2 teaspoonfuls) |
Children under 12 years | Do not use |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients: artificial and natural cherry flavor, citric acid, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, 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 temporarily relieves cough due to minor throat and bronchial irritation helps loosen phlegm (mucus) helps thin bronchial secretions to make coughs more productive
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.GUAIASORB DM Dextromethorphan HBr, Guaifenesin ANHYDROUS CITRIC ACID MENTHOL METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN WATER SODIUM CITRATE 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.Geri Care® GUAIASORB DM SUGAR FREE ♦ DYE FREE ♦ ALCOHOL FREE COUGH SUPPRESSANT EXPECTORANT For ages 12 years and over Dist. By: Geri-Care Pharmaceuticals Corp. 1295 Towbin Avenue Lakewood, NJ 08701 Code# L-014 REV.: 03/23 Principal Display
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.Other information each 10 mL contains: sodium 20 mg TAMPER-EVIDENT: Do not use if foil seal over bottle opening is torn, broken or missing. store at room temperature 15°-30°C (59°-86°F) protect from freezing protect from light
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.
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? 1-800-540-3765
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. • if you have ever had an allergic reaction to any of the ingredients in this product. Ask a doctor before use if you have a cough with too much phlegm (mucus) a cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema. Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or headache that lasts. These could be signs of a serious condition.
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