Aluminum Hydroxide, Magnesium Hydroxide and Simethicone ALUMINUM HYDROXIDE MAGNESIUM HYDROXIDE AND SIMETHICONE RISING PHARMA HOLDINGS, INC. FDA Approved Uses relieves • heartburn • sour stomach • acid indigestion • the symptoms referred to as gas

Drug Facts

Composition & Profile

Active Ingredients
1 200-1 200-120 mg/30 mL Active ingredient per 30mL (1 Unit Dose) Aluminum hydroxide 1 200mg (equivalent to dried gel USP) Magnesium hydroxide 1 200mg Simethicone 120mg 2 400-2 400-240 mg/30 mL Active ingredient per 30mL (1 Unit Dose) Aluminum hydroxide 2 400mg (equivalent to dried gel USP) Magnesium hydroxide 2 400mg Simethicone 240mg ​Purpose Antacid Antigas
Inactive Ingredients
1 200-1 200-120 mg/30 mL / 2 400-2 400-240 mg/30 mL Inactive ingredients benzyl alcohol butylparaben carboxy-methycellulose sodium flavor hypromellose microcrystalline cellulose propylparaben purified water saccharin sodium sorbitol solution
Strengths
120 mg/30 ml 30 ml 1 unit 1200 mg 120 mg 240 mg/30 ml 2400 mg 240 mg
Quantities
30 ml
Treats Conditions
Uses Relieves Heartburn Sour Stomach Acid Indigestion The Symptoms Referred To As Gas

Identifiers & Packaging

Container Type UNKNOWN
UNII
5QB0T2IUN0 NBZ3QY004S 92RU3N3Y1O
Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 1,200-1,200-120 mg/30 mL Case Label NDC 57237-316-31 1,200-1,200-120 mg/30 mL Lid Label NDC 57237-316-03 2,400-2,400-240 mg/30 mL Case Label NDC 57237-324-31 2,400-2,400-240 mg/30 mL Lid Label NDC 57237-324-03 Mag-Al-Case-Lab-01 Mag-Al-Lid-Lab-01 Mag-Al-Case-Lab-02 Mag-Al-Lid-Lab-02

Package Descriptions
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 1,200-1,200-120 mg/30 mL Case Label NDC 57237-316-31 1,200-1,200-120 mg/30 mL Lid Label NDC 57237-316-03 2,400-2,400-240 mg/30 mL Case Label NDC 57237-324-31 2,400-2,400-240 mg/30 mL Lid Label NDC 57237-324-03 Mag-Al-Case-Lab-01 Mag-Al-Lid-Lab-01 Mag-Al-Case-Lab-02 Mag-Al-Lid-Lab-02

Overview

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

Indications & Usage

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

Dosage & Administration

Directions • shake well before use 1,200-1,200-120 mg/30 mL • Do not use more than 4 unit dose (120 mL) in a 24 hour period or use the maximum dose for more than 2 weeks age dose Adults and children over 12 years of age Take 30 mL, one unit dose, between meals and at bedtime, or as directed by a doctor. Do not exceed 4 x 30 mL unit dose (120 mL) in a 24 hour period Children under 12 years of age Ask a doctor 2,400-2,400-240 mg/30 mL • Do not use more than 2 unit dose (60 mL) in a 24 hour period or use the maximum dose for more than 2 weeks age dose Adults and children over 12 years of age Take 30 mL, one unit dose, one to two times daily or as directed by a doctor. Do not exceed 2 x 30 mL unit dose (60 mL) in a 24 hour period Children under 12 years of age Ask a doctor

Warnings & Precautions
Warnings Ask a doctor before use if you have • kidney disease • a 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 healthcare professional before use Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)
Purpose

Drug Facts 1,200-1,200-120 mg/30 mL Active ingredient per 30mL (1 Unit Dose) Aluminum hydroxide 1,200mg (equivalent to dried gel USP) Magnesium hydroxide 1,200mg Simethicone 120mg 2,400-2,400-240 mg/30 mL Active ingredient per 30mL (1 Unit Dose) Aluminum hydroxide 2,400mg (equivalent to dried gel USP) Magnesium hydroxide 2,400mg Simethicone 240mg ​Purpose Antacid Antigas

Stop Use & Ask a Doctor

Stop use and ask a doctor if symptoms last more than 2 weeks

Keep Out of Reach of Children

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)

Storage & Handling

Other information 1,200-1,200-120 mg/30 mL • each 30 mL (unit dose) contains magnesium 510 mg and sodium 18 mg • store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] • protect from freezing • do not use if lid is torn or broke 2,400-2,400-240 mg/30 mL • each 30 mL (unit dose) contains magnesium 990 mg and sodium 6 mg • store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] • protect from freezing • do not use if lid is torn or broken

Questions

NDC Information - 1,200-1,200-120 mg/30 mL Each 30 mL of Aluminium Hydroxide / Magensium Hydroxide / Simethicone contains Aluminum hydroxide 1,200 mg, Magnesium hydroxide 1,200 mg and Simethicone 120 mg and is supplied in the following oral dosage forms: NDC 57237-316-03 unit dose cup 30 mL NDC 57237-316-31 (100 x 30 mL) unit-dose cups 2,400-2,400-240 mg/30 mL Each 30 mL of Aluminium Hydroxide / Magensium Hydroxide / Simethicone contains Aluminum hydroxide 2,400 mg, Magnesium hydroxide 2,400 mg and Simethicone 240 mg and is supplied in the following oral dosage forms: NDC 57237-324-03 unit dose cup 30 mL NDC 57237-324-31 (100 x 30 mL) unit-dose cups


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