FDA Label for Aluminum Hydroxide, Magnesium Hydroxide And Simethicone Suspension
View Indications, Usage & Precautions
Aluminum Hydroxide, Magnesium Hydroxide And Simethicone Suspension Product Label
The following document was submitted to the FDA by the labeler of this product Major� Pharmaceuticals. 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 ingredients (in each 30 mL) Purpose
Aluminum hydroxide 1,200 mg (equivalent to dried gel, USP)..............Antacid
Magnesium hydroxide 1,200 mg......................................................Antacid
Simethicone 120 mg......................................................................Antigas
2,400-2,400-240 mg/30 mL
Active ingredient (in each 30 mL) Purpose
Aluminum hydroxide 2,400 mg (equivalent to dried gel, USP)..............Antacid
Magnesium hydroxide 2,400 mg......................................................Antacid
Simethicone 240 mg......................................................................Antigas
Warnings
Directions • Shake Well Before Use
1,200-1,200-120 mg/30 mL
age | dose |
Adults and children 12 years and older | 30mL, not more than 120 mL in 24 hrs |
Children under 6 years of age | Do not use unless directed by a doctor |
2,400-2,400-240 mg/30 mL
age | dose |
Adults and children 12 years and older | 30mL, not more than 60 mL in 24 hrs |
Children under 6 years of age | Do not use unless directed by a doctor |
Other Information
1,200-1,200-120 mg/30 mL
- each 30 mL containsmagnesium 510 mg and sodium 18 mg
- protect from freezing
- store at 20° to 25°C (68° to 77°F).
- do not use if lid seal is open or damaged
- retain this insert for full product information
- each 30 mL containsmagnesium 990 mg, sodium 30 mg
- store at 20° to 25°C (68° to 77°F).
- protect from freezing
- do not use if lid seal is open or damaged
- retain this insert for full product information
2,400-2,400-240 mg/30 mL
Package Label.Principal Display Panel
MAJOR®
NDC 0904-7325-62
Each 30 mL Contains:
Magnesium hydroxide 1,200 mg
Aluminum hydroxide 1,200 mg
Simethicone 120 mg
SHAKE WELL
Delivers 30 mL • See insert
For Institutional Use Only
MAJOR® PHARMACEUTICALS
Indianapolis, IN 46268
MAJOR®
NDC 0904-7326-62
Each 30 mL Contains:
Magnesium hydroxide 2,400 mg
Aluminum hydroxide 2,400 mg
Simethicone 240 mg
SHAKE WELL
Delivers 30 mL • See insert
For Institutional Use Only
MAJOR® PHARMACEUTICALS
Indianapolis, IN 46268
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