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| Product NDC Code | 81033-102 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Guaifenesin |
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| Type | Generic | ||||||
| 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 | LIQUID | ||||||
| RxCUI drug identifier | 310604 | ||||||
| Application Number | M012 | ||||||
| Labeler Name | KESIN PHARMA CORPORATION | ||||||
| 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.Description Each 5mL (1 teaspoonful) contains: Guaifenesin 100mg
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 Follow dosage below or use as directed by a physician. Do not take more than 6 doses in any 24-hour period Age Dose Adults and children 12 years and over 10 to 20mL (2 to 4 teaspoonfuls) every 4 hours Children 6 years to under 12 years 5 to 10mL (1 to 2 teaspoonfuls) every 4 hours Children 2 to under 6 years of age 2.5 to 5mL (1/2 to 1 teaspoonful) every 4 hours Children under 2 years of age Consult a physician
| Age | Dose |
| Adults and children 12 years and over | 10 to 20mL (2 to 4 teaspoonfuls) every 4 hours |
| Children 6 years to under 12 years | 5 to 10mL (1 to 2 teaspoonfuls) every 4 hours |
| Children 2 to under 6 years of age | 2.5 to 5mL (1/2 to 1 teaspoonful) every 4 hours |
| Children under 2 years of age | Consult a physician |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Mixture of Guaifenesin with GRAS material additions including Citric Acid, Grape Flavor Methylparaben, Monoammonium Glycyrrhizate, Potassium Citrate, Propylene Glycol, Propylparaben, Purified Water, 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 make coughs more productive.
Purpose
Information about the drug product’s indications for use.Guaifenesin Expectorant Sugar Free / Dye Free / Alcohol Free
Spl product data elements
Usually a list of ingredients in a drug product.Guaifenesin Guaifenesin CITRIC ACID MONOHYDRATE METHYLPARABEN AMMONIUM GLYCYRRHIZATE POTASSIUM CITRATE ANHYDROUS PROPYLENE GLYCOL PROPYLPARABEN WATER SORBITOL SUCRALOSE 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 - 5 mL Unit Dose Cup Label NDC 81033-102-51 Guaifenesin Oral Solution, USP Delivers 100mg per 5mL FOR INSTITUTIONAL USE ONLY 50 X 5 mL Unit Dose Cups Store at 59°F to 86°F (15°C to 30°C) 5 mL cup label
PRINCIPAL DISPLAY PANEL - 10 mL Unit Dose Cup Label NDC 81033-102-52 Guaifenesin Oral Solution, USP Delivers 200mg per 10mL FOR INSTITUTIONAL USE ONLY 50 X 10 mL Unit Dose Cups Store at 59°F to 86°F (15°C to 30°C) 10 mL cup label
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.Guaifenesin Oral Solution is a clear, colorless solution with a grape flavor, free of visible foreign matter supplied in the following oral dosage forms: NDC 81033-102-05 Guaifenesin 100mg/5mL (Unit Dose Cup 5mL) NDC 81033-102-10 Guaifenesin 200mg/10mL (Unit Dose Cup 10mL) STORAGE Keep tightly closed. Store at 15-30°C (59-86°F)
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.Stop and ask a doctor if cough lasts mor than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. you are hypersensitive to any of the ingredients
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 Call 1-833-537-4679
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 Ask a doctor before us if you have cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
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