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| Product NDC Code | 0536-1314 | ||||
|---|---|---|---|---|---|
| Drug Name | Chest congestion relief |
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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 | LIQUID | ||||
| RxCUI drug identifier | 310604 | ||||
| Application Number | part341 | ||||
| Labeler Name | RUGBY LABORATORIES | ||||
| 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 ingredients 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 Do not take more than 6 doses in a 24 hour period Do not exceed recommended dose Adults and children 12 years and over 2 to 4 teaspoonfuls every 4 hours children under 12 years ask a doctor
| Adults and children 12 years and over | 2 to 4 teaspoonfuls every 4 hours |
| children under 12 years | ask a doctor |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients. Artificial and natural cherry flavor, citric acid, FD&C Red #40, menthol, methylparaben, propylene glycol, propylparaben water, sodium citrate, 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 lossen 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.Chest Congestion Relief Guaifenesin GUAIFENESIN GUAIFENESIN ANHYDROUS CITRIC ACID FD&C RED NO. 40 MENTHOL METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN water sodium citrate SUCRALOSE
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.chestcongest
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 (1-800-222-1222) 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? 1-800-645-2158
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 Do not use if you ever had an allergic reaction to any of the indregients in 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.
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