MELOX- aluminum hydroxide, magnesium hydroxide, simethicone suspension

Melox by

Drug Labeling and Warnings

Melox by is a Otc medication manufactured, distributed, or labeled by Belmora LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

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

Questions or comments?

1-888-779-2877

SPL UNCLASSIFIED SECTION

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,
2231 Crystal Dr.#1000,
Arlington, VA 22202
www.melox.com

Packaging

INGREDIENTS AND APPEARANCE

MELOX 
aluminum hydroxide, magnesium hydroxide, simethicone suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 27854-115
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0)	ALUMINUM HYDROXIDE	200 mg  in 5 mL
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM HYDROXIDE	200 mg  in 5 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	20 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 27854-115-01	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part331	06/01/2018

Labeler - Belmora LLC (112753244)