Melox Liquid
FDA Label NDC 27854-117
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Belmora Llc for the product Melox (NDC 27854-117). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, active ingredients (in each 10 ml), purpose, uses, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients (In Each 10 Ml)
Aluminum hydroxide (equiv. to dried gel, USP) 400 mg
Magnesium hydroxide 400 mg
Simethicone 40 mg
Purpose
Antacid
Antacid
Antigas
Uses
relieves: • acid indigestion • heartburn • sour stomach • upset stomach and gas associated with these symptoms
Warnings
Do not take more than 80 mL in a 24-hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a doctor.
Ask a doctor before use if you have • kidney disease • a magnesium-restricted diet
Ask a doctor or pharmacist before use if you are • presently taking a prescription drug. Antacids may interact with certain prescription drugs.
Stop use and ask a doctor if symptoms last more than two weeks
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Directions
• shake well before use • adults and children 12 years and older: take 10 - 20 mL four times a day, or as directed by a doctor • children under 12 years: consult a doctor • mL = milliliter
Other Information
• each 10 mL contains: magnesium 170 mg, sodium 5 mg • store at 20°C-25°C (68°F-77°F) • do not freeze
Inactive Ingredients
ethyl alcohol, flavor, glycerin, hydroxyethyl cellulose, methylparaben, propylene glycol, propylparaben, purified water, saccharin sodium, simethicone emulsion, sorbitol.
Packaging
Melox-117 (2785411701)
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