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| Product NDC Code | 24689-122 | ||||||
|---|---|---|---|---|---|---|---|
| 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 | TABLET | ||||||
| RxCUI drug identifier | 359601 | ||||||
| Application Number | part341 | ||||||
| Labeler Name | APNAR PHARMA LP | ||||||
| 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.Drug Facts Active Ingredient (per tablet) Guaifenesin USP............. 400 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 Adults and children 12 years of age and over: take 1 tablet every 4 hours as needed Children 6 to 12 years of age: take 1/2 tablet every 4 hours as needed Children under 6 years of age : consult a doctor Do not exceed 6 doses in a 24 hour period or as directed by a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Microcrystalline cellulose, Croscarmellose sodium, Povidone, Silicon dioxide, magnesium stearate
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.Use helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus helps 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 CROSCARMELLOSE SODIUM POVIDONE K30 SILICON DIOXIDE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE GUAIFENESIN GUAIFENESIN WATER LT;12 White to off White color
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.APNAR PHARMA LP NDC : 24689-122-01 Guaifenesin Tablets 400mg-20's Tablets APNAR PHARMA LP NDC : 24689-122-02 Guaifenesin Tablets 400mg-500's Tablets Guaifenesin Tablets 400mg_20s Tablets Guaifenesin Tablets 400mg_500s
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.Distributed by: APNAR PHARMA LP CHINO, CA, 91710 Rev.: 04/2022
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 immediately.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or concerns? 1-855-642-2594
Storage and handling
Information about safe storage and handling of the drug product.Other Information store at 15°-30°C (59°-86°F)
Boxed warning
Information about contraindications or serious warnings, particularly those that may lead to death or serious injury.Caution: do not use if imprinted seal under cap is broken or missing.
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 doctor before use if you have persistent or chronic cough, such as occurs with smoking, asthma, bronchitis or emphysema cough accompanied by excessive phlegm (mucus) Stop use and ask a doctor if Symptoms are accompanied by fever, rash or persistent headache cough persists for more than 1 week or tends to recur A persistent cough may be a sign of a serious condition If pregnant or breast-feeding , ask a health professional before use.
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