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 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.
Drug Facts
Active ingredients Purpose
(in each 5 mL = 1 teaspoonful)
Aluminum hydroxide (equiv. to dried gel, USP) 200 mg .......................... Antacid
Magnesium hydroxide 200 mg .............................................................. Antacid
Simethicone 20 mg ............................................................................... Antigas
Warnings
Do not take more than 16 teaspoonfuls in a 24-hour period or use the maximum dosage for more than 2 weeks except under the advice and supervision of a physician.
Ask A Doctor Before Use If You Have
- kidney disease
- a magnesium-restricted diet
Directions
- shake well before using
- do not take more than 16 teaspoonfuls in 24 hours or use the maximum dosage for more than 2 weeks
| adults and children 12 years and older | take 2 to 4 teaspoonfuls four times a day or as directed by a physician |
| children under 12 years | consult a physician |
Other Information
- each 5 mL contains: magnesium 83 mg, sodium 1.34 mg
- store at controlled room temperature 20° - 25°C (68° - 77°F) {See USP Controlled Room Temperature].
- protect from freezing
- White colored, peppermint flavored liquid supplied in the following oral dosage form:
NDC 0904-7557-62: 30 mL unit dose cup, in a tray of ten cups.
Principal Display Panel - 30 Ml Unit-Dose Cup Lidding Label
MAJOR®
NDC 0904-7557-62
Each 30 mL Contains:
Magnesium Hydroxide 1200 mg
Aluminum Hydroxide 1200 mg
Simethicone 120 mg
SHAKE WELL
Delivers 30 mL • See insert
For Institutional Use Only
MAJOR® PHARMACEUTICALS
Indianapolis, IN 46268
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