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| Product NDC Code | 24689-123 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Guaifenesin and dextromethorphan hydrobromide |
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| Type | Generic | ||||||
| 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 | TABLET | ||||||
| RxCUI drug identifier | 1147685 | ||||||
| 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 Ingredients (per tablet) Guaifenesin USP...................................... 400 mg Dextromethorphan Hydrobromide USP...... 20 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 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.Uses: Temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold 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 Cough suppressant
Spl product data elements
Usually a list of ingredients in a drug product.Guaifenesin and Dextromethorphan Hydrobromide Guaifenesin and Dextromethorphan Hydrobromide CELLULOSE, MICROCRYSTALLINE POVIDONE K30 WATER GUAIFENESIN GUAIFENESIN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN CROSCARMELLOSE SODIUM SILICON DIOXIDE MAGNESIUM STEARATE LT13
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 24689-123-01 Guaifenesin and Dextromethorphan Hydrobromide Tablets 400 + 20mg- 20s tablets APNAR PHARMA LP NDC 24689-123-02 Guaifenesin and Dextromethorphan Hydrobromide Tablets 400 + 20mg- 500s tablets Guaifenesin and Hbr tablets 400+20mg- 20s tablets Guaifenesin and Hbr tablets 400+20mg- 500s tablets
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 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 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 using this product. Ask a doctor before use if you have Persistent or chronic cough, such as occurs with smoking, asthma, chronic bronchitis or emphysema Cough accompanied by excessive phegm (mucus) Stop use and ask a doctor if Symptons 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 healthcare 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