Aluminum Hydroxide, Magnesium Hydroxide And Simethicone Suspension
FDA Label NDC 57237-324

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rising Pharma Holdings, Inc. for the product Aluminum Hydroxide, Magnesium Hydroxide And Simethicone (NDC 57237-324). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - purpose, warnings, directions • shake well before use, other information, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - 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

Warnings

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

 agedose
Adults and children over 12 years of ageTake 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 ageAsk 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

 agedose
Adults and children over 12 years of ageTake 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 ageAsk a doctor

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

Package Label.Principal Display Panel

1,200-1,200-120 mg/30 mL

Case Label NDC 57237-316-31

Mag-al-case-lab-01 (Mag Al Case Lab 01)

Mag-al-case-lab-01 (Mag Al Case Lab 01)

1,200-1,200-120 mg/30 mL

Lid Label NDC 57237-316-03

Mag-al-lid-lab-01 (Mag Al Lid Lab 01)

Mag-al-lid-lab-01 (Mag Al Lid Lab 01)

2,400-2,400-240 mg/30 mL

Case Label NDC 57237-324-31

Mag-al-case-lab-02 (Mag Al Case Lab 02)

Mag-al-case-lab-02 (Mag Al Case Lab 02)

2,400-2,400-240 mg/30 mL
Lid Label NDC 57237-324-03

Mag-al-lid-lab-02 (Mag Al Lid Lab 02)

Mag-al-lid-lab-02 (Mag Al Lid Lab 02)

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