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| Product NDC Code | 0121-2232 | ||||
|---|---|---|---|---|---|
| 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 | SOLUTION | ||||
| Application Number | M012 | ||||
| Labeler Name | PAI Holdings, LLC dba PAI Pharma | ||||
| 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 5 mL (1 teaspoonful) contains: Guaifenesin 100 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 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 20 mL (2 to 4 teaspoonfuls) every 4 hours children 6 years to under 12 years 5 to 10 mL (1 to 2 teaspoonfuls) every 4 hours children 2 to under 6 years of age 2.5 to 5 mL (½ 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 20 mL (2 to 4 teaspoonfuls) every 4 hours |
| children 6 years to under 12 years | 5 to 10 mL (1 to 2 teaspoonfuls) every 4 hours |
| children 2 to under 6 years of age | 2.5 to 5 mL (½ 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 Acesulfame K, citric acid, FD&C Green No. 3, FD&C Red No. 40, flavoring, hydroxyethylcellulose, purified water, sodium benzoate and sodium citrate. Sodium Content: 4 mg/5 mL
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.Expectorant SUGAR FREE / ALCOHOL FREE
Spl product data elements
Usually a list of ingredients in a drug product.GUAIFENESIN GUAIFENESIN GUAIFENESIN GUAIFENESIN ACESULFAME POTASSIUM FD&C GREEN NO. 3 FD&C RED NO. 40 HYDROXYETHYL CELLULOSE, UNSPECIFIED WATER SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM ANHYDROUS CITRIC ACID GUAIFENESIN GUAIFENESIN GUAIFENESIN GUAIFENESIN ACESULFAME POTASSIUM FD&C GREEN NO. 3 FD&C RED NO. 40 HYDROXYETHYL CELLULOSE, UNSPECIFIED WATER SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM ANHYDROUS CITRIC ACID GUAIFENESIN GUAIFENESIN GUAIFENESIN GUAIFENESIN ANHYDROUS CITRIC ACID ACESULFAME POTASSIUM FD&C GREEN NO. 3 FD&C RED NO. 40 HYDROXYETHYL CELLULOSE, UNSPECIFIED WATER SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM GUAIFENESIN GUAIFENESIN GUAIFENESIN GUAIFENESIN ANHYDROUS CITRIC ACID ACESULFAME POTASSIUM FD&C GREEN NO. 3 FD&C RED NO. 40 HYDROXYETHYL CELLULOSE, UNSPECIFIED WATER SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM
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 - 473 mL Bottle Label NDC 0121-0744-16 Quality ® Value Guaifenesin Oral Solution USP 100 mg/5 mL EXPECTORANT Compare to the active ingredient in *Robitussin® SUGAR FREE/ALCOHOL FREE LOOSENS AND RELIEVES CHEST CONGESTION 16 fl oz (473 mL) Pharmaceutical Associates, Inc. Greenville, SC 29605 PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 5 mL Cup Label Delivers 5 mL NDC 0121-1744-05 G UAIFENESIN O RAL S OLUTION USP 100 mg/5 mL Sugar Free/Alcohol Free EXPECTORANT Package Not Child-Resistant PHARMACEUTICAL ASSOCIATES, INC. GREENVILLE, SC 29605 SEE INSERT PRINCIPAL DISPLAY PANEL - 5 mL Cup Label
PRINCIPAL DISPLAY PANEL - 10 mL Cup Label Delivers 10 mL NDC 0121-1488-10 G UAIFENESIN O RAL S OLUTION USP 200 mg/10 mL Sugar Free/Alcohol Free EXPECTORANT Package Not Child-Resistant PHARMACEUTICAL ASSOCIATES, INC. GREENVILLE, SC 29605 SEE INSERT PRINCIPAL DISPLAY PANEL - 10 mL Cup Label
PRINCIPAL DISPLAY PANEL - 15 mL Cup Label Delivers 15 mL NDC 0121-2232-15 G UAIFENESIN O RAL S OLUTION USP 300 mg/15 mL Sugar Free/Alcohol Free EXPECTORANT Package Not Child-Resistant PHARMACEUTICAL ASSOCIATES, INC. GREENVILLE, SC 29605 SEE INSERT PRINCIPAL DISPLAY PANEL - 15 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.Professional Note Guaifenesin has been shown to produce a color interference with certain clinical laboratory determinations of 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).
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 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
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 a doctor if cough lasts more 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.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.Guaifenesin Oral Solution USP is a red, raspberry flavored solution supplied in the following oral dosage forms: NDC 0121-0744-04: 4 fl oz (120 mL) bottle NDC 0121-0744-08: 8 fl oz (237 mL) bottle NDC 0121-0744-16: 16 fl oz (473 mL) bottle NDC 0121-1744-05: 5 mL unit dose cup NDC 0121-1744-00: Case contains 100 unit dose cups of 5 mL (0121-1744-05) packaged in 10 trays of 10 unit dose cups each. NDC 0121-1488-10: 10 mL unit dose cup NDC 0121-1488-00: Case contains 100 unit dose cups of 10 mL (0121-1488-10) packaged in 10 trays of 10 unit dose cups each. NDC 0121-2232-15: 15 mL unit dose cup NDC 0121-2232-00: Case contains 100 unit dose cups of 15 mL (0121-2232-15) packaged in 10 trays of 10 unit dose cups each.
Storage and handling
Information about safe storage and handling of the drug product.STORAGE Keep tightly closed. Store at controlled room temperature, 20°-25°C (68°-77°F). [See USP] Protect from light.
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 use 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 Stop use and ask a doctor if cough lasts more 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. 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 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