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| Product NDC Code | 84447-101 | ||||||||
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| Drug Name | Guaifenesin 100mg/5ml |
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| Type | Brand | ||||||||
| 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 | Belleview Biosciences | ||||||||
| 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.Active Ingredient (in each 5 mL tsp) 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.Dosage & Admin Directions: ■ do not take more than 6 doses in any 24-hour period. AGE DOSE Adults & Children 12 years and over 2-4 teaspoonfuls every 4 hours Children 6 years to under 12 years 1-2 teaspoonfuls every 4 hours Children 2 to under 6 years 1/2 - 1 teaspoonfuls every 4 hours Children Under 2 years Ask a Doctor
| AGE | DOSE |
| Adults & Children 12 years and over | 2-4 teaspoonfuls every 4 hours |
| Children 6 years to under 12 years | 1-2 teaspoonfuls every 4 hours |
| Children 2 to under 6 years | |
| Children Under 2 years | Ask a Doctor |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Citric Acid, Flavor, Methylparaben, Monoammonium Glycyrrhizinate, 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.Purpose: Expectorant
Spl product data elements
Usually a list of ingredients in a drug product.Guaifenesin 100mg/5mL Guaifenesin PROPYLENE GLYCOL SUCRALOSE PROPYLPARABEN POTASSIUM CITRATE METHYLPARABEN ANHYDROUS CITRIC ACID AMMONIUM GLYCYRRHIZATE SORBITOL WATER 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.84447-101 Bulk Label
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.
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 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. If pregnant of 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