MELOX- aluminum hydroxide, magnesium hydroxide, simethicone liquid 
Belmora LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Melox

Drug Facts

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

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.

Belmora LLC

ALUMINA, MAGNESIA, AND SIMETHICONE ORAL SUSPENSION

HEARTBURN RELIEF

MINT CREME FLAVOR

DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING

Packaging

Melox-117

MELOX 
aluminum hydroxide, magnesium hydroxide, simethicone liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:27854-117
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE400 mg  in 10 mL
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM HYDROXIDE400 mg  in 10 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE40 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:27854-117-01355 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33105/01/2023
Labeler - Belmora LLC (112753244)

Revised: 5/2023
Document Id: 30664d3b-521c-4914-9c59-88688f8f63d4
Set id: bfc78d44-dc90-4f69-85af-a23dd70c68d2
Version: 1
Effective Time: 20230519
 
Belmora LLC