FDA Label for Aluminum Hydroxide, Magnesium Hydroxide And Simethicone
View Indications, Usage & Precautions
Aluminum Hydroxide, Magnesium Hydroxide And Simethicone Product Label
The following document was submitted to the FDA by the labeler of this product Rising Pharma Holdings, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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
| 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 |
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
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
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