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| Product NDC Code | 27854-115 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Melox |
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| Type | Brand | ||||||
| Pharm Class | Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Skin Barrier Activity [PE], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] |
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| Active Ingredients |
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| Route | ORAL | ||||||
| Dosage Form | SUSPENSION | ||||||
| RxCUI drug identifier | 307746 | ||||||
| Application Number | part331 | ||||||
| Labeler Name | Belmora LLC | ||||||
| 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 (in each 5 mL teaspoonful) Aluminum hydroxide 200 mg (equivalent to dried gel USP) Magnesium hydroxide 200 mg Simethicone 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 • shake well before each use • adults and children 12 years and older: take 2 to 4 teaspoonfuls between meals, at bedtime, or as directed by a doctor • do not exceed 16 teaspoonfuls in a 24 hour period or use the maximum dosage for more than 2 weeks • children under 12: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients benzyl alcohol, butylparaben, carboxymethylcellulose sodium, flavor, hypromellose, microcrystalline cellulose, propylparaben, purified water, saccharin sodium, sorbitol solution
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 relieves • acid indigestion • heartburn • sour stomach • the symptoms referred to as gas
Purpose
Information about the drug product’s indications for use.Purpose Antacid Antacid Antigas
Spl product data elements
Usually a list of ingredients in a drug product.Melox Aluminum hydroxide, Magnesium hydroxide, Simethicone ALUMINUM HYDROXIDE ALUMINUM HYDROXIDE MAGNESIUM HYDROXIDE MAGNESIUM CATION DIMETHICONE DIMETHICONE BENZYL ALCOHOL BUTYLPARABEN CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM HYPROMELLOSE, UNSPECIFIED MICROCRYSTALLINE CELLULOSE PROPYLPARABEN WATER SACCHARIN SODIUM SORBITOL SOLUTION
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.Packaging Melox1
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.Drug Facts
HEARTBURN RELIEF TAMPER EVIDENT: Do not use if breakaway band on cap is broken or missing. *This product is not manufactured or distributed by the owner of the registered trademark Maalox ® Distributed by: Belmora LLC, 2011 Crystal Dr.#400, Arlington, VA 22202 www.melox.com
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.
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? 1-888-779-2877
Storage and handling
Information about safe storage and handling of the drug product.Other information • each 5 mL teaspoonful contains: magnesium 85 mg, sodium 3 mg • store at room temperature • protect from freezing • keep tightly closed
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 • kidney disease • magnesium-restricted diet Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids may interact with certain prescription drugs. Stop use and ask a doctor if symptoms last more than 2 weeks If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children.
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