Melox

Melox
SPL v2
SPL
SPL Set ID bfc78d44-dc90-4f69-85af-a23dd70c68d2
Route
ORAL
Published
Effective Date 2023-05-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aluminum Hydroxide (400 mg) Magnesium Cation (40 mg) Dimethicone
Inactive Ingredients
Alcohol Glycerin Hydroxyethyl Cellulose, Unspecified Methylparaben Propylene Glycol Propylparaben Water Saccharin Sodium Sorbitol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-05-01

Description

Aluminum hydroxide (equiv. to dried gel, USP) 400 mg Magnesium hydroxide 400 mg Simethicone 40 mg

Purpose

Antacid Antacid Antigas


Medication Information

Purpose

Antacid

Antacid

Antigas

Description

Aluminum hydroxide (equiv. to dried gel, USP) 400 mg Magnesium hydroxide 400 mg Simethicone 40 mg

Uses

relieves: • acid indigestion • heartburn • sour stomach • upset stomach and gas associated with these symptoms

Section 42229-5

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

Section 50565-1

Keep out of reach of children.

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

Packaging

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

Drug Facts

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.

Active Ingredients (in Each 10 Ml)

Aluminum hydroxide (equiv. to dried gel, USP) 400 mg

Magnesium hydroxide 400 mg

Simethicone 40 mg


Structured Label Content

Uses

relieves: • acid indigestion • heartburn • sour stomach • upset stomach and gas associated with these symptoms

Section 42229-5 (42229-5)

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

Section 50565-1 (50565-1)

Keep out of reach of children.

Purpose

Antacid

Antacid

Antigas

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

Packaging

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

Drug Facts

Other Information (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 (Inactive ingredients)

ethyl alcohol, flavor, glycerin, hydroxyethyl cellulose, methylparaben, propylene glycol, propylparaben, purified water, saccharin sodium, simethicone emulsion, sorbitol.

Active Ingredients (in Each 10 Ml) (Active ingredients (in each 10 mL))

Aluminum hydroxide (equiv. to dried gel, USP) 400 mg

Magnesium hydroxide 400 mg

Simethicone 40 mg


Advanced Ingredient Data


Raw Label Data

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