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| Product NDC Code | 0121-0638 | ||||||||||
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| Drug Name | Guaifenesin 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 | SYRUP | ||||||||||
| RxCUI drug identifier | 996520 | ||||||||||
| Application Number | M012 | ||||||||||
| Labeler Name | PAI Holdings, LLC | ||||||||||
| 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 Dextromethorphan Hydrobromide 10 mg Inactive Ingredients: Citric acid, FD&C Red No. 40, flavoring, glycerin, menthol, purified water, sodium benzoate, sodium citrate, sodium saccharin, and sucrose. Sodium Content: 4 mg/5 mL
| Each 5 mL (1 teaspoonful) contains: | |
| Guaifenesin | 100 mg |
| Dextromethorphan Hydrobromide | 10 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 mL (2 teaspoonfuls) every 4 hours children 6 years to under 12 years 5 mL (1 teaspoonful) every 4 hours children 2 years to under 6 years 2.5 mL (1/2 teaspoonful) every 4 hours children under 2 years ask a doctor
| age | dose |
|---|---|
| adults and children 12 years and over | 10 mL (2 teaspoonfuls) every 4 hours |
| children 6 years to under 12 years | 5 mL (1 teaspoonful) every 4 hours |
| children 2 years to under 6 years | 2.5 mL (1/2 teaspoonful) every 4 hours |
| children under 2 years | ask a doctor |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Citric acid, FD&C Red No. 40, flavoring, glycerin, menthol, purified water, sodium benzoate, sodium citrate, sodium saccharin, and sucrose. 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 temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
Purpose
Information about the drug product’s indications for use.Non-Narcotic, Alcohol Free Expectorant/Cough Suppressant
Spl product data elements
Usually a list of ingredients in a drug product.GUAIFENESIN DM GUAIFENESIN and DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN DEXTROMETHORPHAN DEXTROMETHORPHAN DEXTROMETHORPHAN HYDROBROMIDE ANHYDROUS CITRIC ACID FD&C RED NO. 40 GLYCERIN MENTHOL WATER SODIUM BENZOATE SODIUM CITRATE SACCHARIN SODIUM SUCROSE GUAIFENESIN DM GUAIFENESIN and DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN DEXTROMETHORPHAN DEXTROMETHORPHAN DEXTROMETHORPHAN HYDROBROMIDE SODIUM BENZOATE SODIUM CITRATE SACCHARIN SODIUM SUCROSE ANHYDROUS CITRIC ACID FD&C RED NO. 40 GLYCERIN MENTHOL WATER
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 Delivers 5 mL NDC 0121-0638-05 GUAIFENESIN SYRUP and DEXTROMETHORPHAN 100 mg/10 mg per 5 mL Package Not Child-Resistant PHARMACEUTICAL ASSOCIATES, INC. GREENVILLE, SC 29605 SEE INSERT 5 mL unit dose cup label
PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label NDC 0121-0638-04 NSN 6505-01-318-1565 Quality ® Value Guaifenesin-DM 100 mg/10 mg per 5 mL EXPECTORANT/COUGH SUPPRESSANT Compare to the active ingredients in *Robitussin ®- DM CONTROLS COUGHS LOOSENS AND RELIEVES CHEST CONGESTION 4 fl oz (118 mL) Pharmaceutical Associates, Inc. Greenville, SC 29605 118 mL bottle label
PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label NDC 0121-0638-08 Quality ® Value Guaifenesin-DM 100 mg/10 mg per 5 mL EXPECTORANT/COUGH SUPPRESSANT Compare to the active ingredients in *Robitussin ®- DM CONTROLS COUGHS LOOSENS AND RELIEVES CHEST CONGESTION 8 fl oz (237 mL) Pharmaceutical Associates, Inc. Greenville, SC 29605 237 mL bottle label
PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label NDC 0121-0638-16 Quality ® Value Guaifenesin-DM 100 mg/10 mg per 5 mL EXPECTORANT/COUGH SUPPRESSANT Compare to the active ingredients in *Robitussin ®- DM CONTROLS COUGHS LOOSENS AND RELIEVES CHEST CONGESTION 16 fl oz (473 mL) Pharmaceutical Associates, Inc. Greenville, SC 29605 473 mL bottle label
PRINCIPAL DISPLAY PANEL - 10 mL Unit Dose Cup Label Delivers 10 mL NDC 0121-1276-10 GUAIFENESIN SYRUP and DEXTROMETHORPHAN 200 mg/20 mg per 10 mL Package Not Child-Resistant PHARMACEUTICAL ASSOCIATES, INC. GREENVILLE, SC 29605 SEE INSERT 10 unit dose 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).
MANUFACTURED BY Pharmaceutical Associates, Inc. Greenville, SC 29605 www.paipharma.com R11/16
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
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 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.HOW SUPPLIED: Guaifenesin Syrup and Dextromethorphan is a red, cherry flavored syrup supplied in the following oral dosage forms: NDC 0121-0638-04: 4 fl oz (118 mL) bottle NDC 0121-0638-08: 8 fl oz (237 mL) bottle NDC 0121-0638-16: 16 fl oz (473 mL) bottle NDC 01210638-05: 5 mL unit dose cup NDC 0121-0638-00: Case contains 100 unit dose cups of 5 mL (0121-0638-05) packaged in 10 trays of 10 unit dose cups each. NDC 0121-1276-10: 10 mL unit dose cup NDC 0121-1276-00: Case contains 100 unit dose cups of 10 mL (0121-1276-10) 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 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 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