Melox Suspension
FDA Label NDC 27854-115

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 27854-115). 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 5 ml teaspoonful), 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

Drug Facts

Active Ingredients (In Each 5 Ml Teaspoonful)

Aluminum hydroxide 200 mg (equivalent to dried gel USP)

Magnesium hydroxide 200 mg

Simethicone 20 mg

Purpose

Antacid

Antigas

Uses

relieves   • acid indigestion   • heartburn   • sour stomach   • the symptoms referred to as gas

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.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

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

Other Information

• each 5 mL teaspoonful contains: magnesium 85 mg, sodium 3 mg

• store at room temperature

• protect from freezing

• keep tightly closed

Inactive Ingredients

benzyl alcohol, butylparaben, carboxymethylcellulose sodium, flavor, hypromellose, microcrystalline cellulose, propylparaben, purified water, saccharin sodium, sorbitol solution

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