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NDC 27854-0115-01 Melox 200; 20; 200 mg/5mL; mg/5mL; mg/5mL Details

Melox 200; 20; 200 mg/5mL; mg/5mL; mg/5mL

Melox is a ORAL SUSPENSION in the HUMAN OTC DRUG category. It is labeled and distributed by Belmora LLC. The primary component is ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE.

MedlinePlus Drug Summary

Aluminum Hydroxide, Magnesium Hydroxide are antacids used together to relieve heartburn, acid indigestion, and upset stomach. They may be used to treat these symptoms in patients with peptic ulcer, gastritis, esophagitis, hiatal hernia, or too much acid in the stomach (gastric hyperacidity). They combine with stomach acid and neutralize it. Aluminum Hydroxide, Magnesium Hydroxide are available without a prescription. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Related Packages: 27854-0115-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Aluminum Hydroxide and Magnesium Hydroxide

Simethicone is used to treat the symptoms of gas such as uncomfortable or painful pressure, fullness, and bloating. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Related Packages: 27854-0115-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Simethicone

Product Information

NDC	27854-0115
Product ID	27854-115_cb37d74c-450d-462e-bf2c-8bec9864a35f
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Melox
Proprietary Name Suffix	n/a
Non-Proprietary Name	Aluminum hydroxide, Magnesium hydroxide, Simethicone
Product Type	HUMAN OTC DRUG
Dosage Form	SUSPENSION
Route	ORAL
Active Ingredient Strength	200; 20; 200
Active Ingredient Units	mg/5mL; mg/5mL; mg/5mL
Substance Name	ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE
Labeler Name	Belmora LLC
Pharmaceutical 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
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part331
Listing Certified Through	2024-12-31

Package

Package Images

NDC 27854-0115-01 (27854011501)

Pricing Information	N/A
NDC Package Code	27854-115-01
Billing NDC	27854011501
Package	355 mL in 1 BOTTLE (27854-115-01)
Marketing Start Date	2018-06-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d41f0b26-5add-4045-9754-37d70d120d28 Details

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,

2011 Crystal Dr.#400,

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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 SOLUTION (UNII: 8KW3E207O2)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

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

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

Labeler - Belmora LLC (112753244)

Revised: 11/2020

Document Id: cb37d74c-450d-462e-bf2c-8bec9864a35f

Set id: d41f0b26-5add-4045-9754-37d70d120d28

Version: 2

Effective Time: 20201125