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The constipation is a common side effect with the Tylenol 3, and I was giving her lots of high fibre foods and lots of fluids (water, herbal tea), but the constipation persisted
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In every case where the committee voted yes, it did so against the written recommendation of FDA career staff, who had concluded after months of review that none of the seven substances met the agency's four-part evidentiary standard for inclusion on the 503A Bulk Drug Substances List
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