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Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

the active ingredients included in the package labeling are aluminum hydroxide, magnesium hydroxide, and simethicone. However, the electronic listing file only includes aluminum hydroxide and dimethiconol as the active ingredients while including magnesium hydroxide as an inactive ingredient.

Passage 2

the active ingredients described in the package labeling include sodium citrate, sodium lauryl sulfoacetate, and sorbitol. However, the electronic listing file only includes sorbitol as the active ingredient and sodium lauryl sulfoacetate and sodium citrate (trisodium citrate dihydrate) as inactive ingredients.