The following Structured Product Label (SPL) was submitted to the FDA by Major Pharmaceuticals for the product Aluminum Hydroxide, Magnesium Hydroxide, And Simethicone (NDC 0904-7557). 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 drug facts, warnings, ask a doctor before use if you have, directions, other information, principal display panel - 30 ml unit-dose cup lidding label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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
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.
| 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 |
NDC 0904-7557-62: 30 mL unit dose cup, in a tray of ten cups.
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
30 mL Lidding Label (Mag Al Plus 1)
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