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| Product NDC Code | 10135-790 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Guaifenesin 400mg |
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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 | TABLET | ||||||
| RxCUI drug identifier | 359601 | ||||||
| Application Number | M012 | ||||||
| Labeler Name | Marlex Pharmaceuticals Inc | ||||||
| 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 tablet) Guaifenesin 400mg
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 any 24-hour period. This product is not intended for use in children under 12 years of age Adults & children 12 years and over: 1 to 2 tablets every 4 hours Children under 12 years: do not use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Maltodextrin, Povidone, Silicon Dioxide, Stearic acid. Manufactured for & Distributed by: Marlex Pharmaceuticals, Inc. New Castle, DE 19720 Rev. 03/24 AA
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 rid the bronchial passageway of bothersome mucus and make coughs more productive
Purpose
Information about the drug product’s indications for use.Purpose Expectorant Guaifenesin 4 00 mg Caplets
Spl product data elements
Usually a list of ingredients in a drug product.Guaifenesin 400mg Guaifenesin SILICON DIOXIDE MALTODEXTRIN POVIDONE STEARIC ACID GUAIFENESIN GUAIFENESIN White to off white C16 Caplet
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.PRINCIPAL DISPLAY PANEL NDC 10135-0790-30 Guaifenesin 400 mg 30 CAPLETS 790-30
PRINCIPAL DISPLAY PANEL NDC 10135-0790-60 Guaifenesin 400 mg 60 CAPLETS 790-60
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.GUAIFENESIN 400 MG CAPLETS Marlex Pharmaceuticals, Inc. ---------- Drug Fact
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.
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 last more than 7 days, comes back or is accompanied by fever, rash, or persistent headache. These could be signs of a serious illness. TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast- feeding, ask a health professional before use.
Safe handling warning
Safe Handling WarningOther Information: Store at 15°C-30°C (59°F-86°F)
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 Persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema Cough accompanied by too much phlegm (mucus) Stop use and ask a doctor if cough last more than 7 days, comes back or is accompanied by fever, rash, or persistent headache. These could be signs of a serious illness. TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. 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