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| Product NDC Code | 60687-863 | ||||
|---|---|---|---|---|---|
| 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 | ||||
| RxCUI drug identifier | 310604 | ||||
| Application Number | M012 | ||||
| Labeler Name | American Health Packaging | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each 5 mL Cup) Guaifenesin 100 mg (in each 10 mL Cup) Guaifenesin 200 mg (in each 15 mL Cup) Guaifenesin 300 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 (yr) Dose (ml) 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 years to under 6 years 2.5 to 5 ml (1 /2 to 1 teaspoonful) every 4 hours children under 2 years consult a physician Other Information Each 5 ml contains: sodium 4 mg. Each 10 ml contains: sodium 8 mg. Each 15 ml contains: sodium 12 mg. Store at controlled room temperature between 20° to 25°C (68° to 77°F) [see USP]. Protect from light. DO NOT USE IF SEAL IS BROKEN. Guaifenesin Oral Solution is a red, raspberry flavored solution and is available in the following dosage forms: 5 ml unit-dose cups: 100 cups (10 x 10) NDC 60687-852-17 10 ml unit-dose cups: 100 cups (10 x 10) NDC 60687-863-56 15 ml unit-dose cups: 100 cups (10 x 10) NDC 60687-874-16
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.
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.Purpose Expectorant
Spl product data elements
Usually a list of ingredients in a drug product.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 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.Package/Label Principal Display Panel – 100 mg per 5 mL – Label Case NDC 60687- 852 -17/Cup NDC 60687- 852 -40 Guaifenesin Oral Solution USP Expectorant 100 mg per 5 ml SUGAR FREE / ALCOHOL FREE Raspberry Flavor Usual Dosage: See attached Drug Facts. Store at 20° to 25°C (68° to 77°F) [See USP] Protect from light. FOR INSTITUTIONAL USE ONLY T0744C050624 R0624 100 mg per 5 mL Guaifenesin Oral Solution Label
Package/Label Principal Display Panel – 100 mg per 5 mL – Cup Lid NDC 60687- 852 -40 Guaifenesin Oral Solution, USP Expectorant 100 mg per 5 ml Sugar Free/Alcohol Free Delivers 5 mL PROTECT FROM LIGHT. See package Drug Facts insert for full prescribing information and storage. For Institutional Use Only. American Health Packaging Columbus, OH 43217 F0744C050624 100 mg per 5 mL Guaifenesin Oral Solution Cup Lid
Package/Label Principal Display Panel – 200 mg per 10 mL – Label Case NDC 60687- 863 -56/Cup NDC 60687- 863 -42 Guaifenesin Oral Solution USP Expectorant 200 mg per 10 ml Sodium Content: 8 mg/10 ml SUGAR FREE / ALCOHOL FREE Raspberry Flavor Usual Dosage: See attached Drug Facts. Store at 20° to 25°C (68° to 77°F) [See USP] Protect from light. FOR INSTITUTIONAL USE ONLY T0744C100624 R0624 200 mg per 5 mL Guaifenesin Oral Solution Label
Package/Label Principal Display Panel – 200 mg per 10 mL – Cup Lid NDC 60687- 863 -42 Guaifenesin Oral Solution, USP Expectorant 200 mg per 10 ml Sodium Content: 8 mg/10 ml Sugar Free/Alcohol Free Delivers 10 mL PROTECT FROM LIGHT. See package Drug Facts insert for full prescribing information and storage. For Institutional Use Only. American Health Packaging Columbus, OH 43217 F0744C100624 200 mg per 5 mL Guaifenesin Oral Solution Cup Lid
Package/Label Principal Display Panel – 300 mg per 15 mL – Label Case NDC 60687- 874 -16/Cup NDC 60687- 874 -44 Guaifenesin Oral Solution USP Expectorant 300 mg per 15 ml Sodium Content: 12 mg/15 ml SUGAR FREE / ALCOHOL FREE Raspberry Flavor Usual Dosage: See attached Drug Facts. Store at 20° to 25°C (68° to 77°F) [See USP] Protect from light. FOR INSTITUTIONAL USE ONLY T0744C150624 R0624 300 mg per 5 mL Guaifenesin Oral Solution Label
Package/Label Principal Display Panel – 300 mg per 15 mL – Cup Lid NDC 60687- 874 -44 Guaifenesin Oral Solution, USP Expectorant 300 mg per 15 ml Sodium Content: 12 mg/15 ml Sugar Free/Alcohol Free Delivers 15 mL PROTECT FROM LIGHT. See package Drug Facts insert for full prescribing information and storage. For Institutional Use Only. American Health Packaging Columbus, OH 43217 F0744C150624 300 mg per 5 mL Guaifenesin Oral Solution Cup Lid
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.Expectorant SUGAR FREE / ALCOHOL FREE
Generic Section 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). Distributed by: American Health Packaging Columbus, OH 43217 R0624
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 .
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information Each 5 ml contains: sodium 4 mg. Each 10 ml contains: sodium 8 mg. Each 15 ml contains: sodium 12 mg. Store at controlled room temperature between 20° to 25°C (68° to 77°F) [see USP]. Protect from light. DO NOT USE IF SEAL IS BROKEN. Guaifenesin Oral Solution is a red, raspberry flavored solution and is available in the following dosage forms: 5 ml unit-dose cups: 100 cups (10 x 10) NDC 60687-852-17 10 ml unit-dose cups: 100 cups (10 x 10) NDC 60687-863-56 15 ml unit-dose cups: 100 cups (10 x 10) NDC 60687-874-16
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 1-800-845-8210
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.
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