[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR331.80]

[Page 221-222]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF 
 
PART 331_ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) 
HUMAN USE--Table of Contents
 
                           Subpart D_Labeling
 
Sec. 331.80  Professional labeling.

    (a) The labeling of the product provided to health professionals 
(but not to the general public):
    (1) Shall contain the neutralizing capacity of the product as 
calculated using the procedure set forth in United States Pharmacopeia 
23/National Formulary 18 expressed in terms of the dosage recommended 
per minimum time interval or, if the labeling recommends more than one 
dosage, in terms of the minimum dosage recommended per minimum time 
interval.
    (2) May contain an indication for the symptomatic relief of 
hyperacidity associated with the diagnosis of peptic ulcer, gastritis, 
peptic esophagitis, gastric hyperacidity, and hiatal hernia.
    (3) For products containing basic aluminum carbonate gel identified 
in Sec. 331.11(a)(1)--Indication. ``For the treatment, control, or 
management of hyperphosphatemia, or for use with a low phosphate diet to 
prevent formation of phosphate urinary stones, through the reduction of 
phosphates in the serum and urine.''
    (4) For products containing aluminum identified in Sec. 331.11(a)--
Warnings. (i) Prolonged use of aluminum-containing antacids in patients 
with renal failure may result in or worsen dialysis osteomalacia. 
Elevated tissue aluminum levels contribute to the development of the 
dialysis encephalopathy and osteomalacia syndromes. Small amounts of 
aluminum are absorbed from the gastrointestinal tract and renal 
excretion of aluminum is impaired in renal failure. Aluminum is not well 
removed by dialysis because it is bound to albumin and transferrin, 
which do not cross dialysis membranes. As a result, aluminum is 
deposited in bone, and dialysis osteomalacia may develop when large 
amounts of aluminum are ingested orally by patients with impaired renal 
function.

[[Page 222]]

    (ii) Aluminum forms insoluble complexes with phosphate in the 
gastrointestinal tract, thus decreasing phosphate absorption. Prolonged 
use of aluminum-containing antacids by normophosphatemic patients may 
result in hypophosphatemia if phosphate intake is not adequate. In its 
more severe forms, hypophosphatemia can lead to anorexia, malaise, 
muscle weakness, and osteomalacia.
    (b) Professional labeling for an antacid-antiflatulent combination 
may contain the information allowed for health professionals for 
antacids and antiflatulents.

[39 FR 19874, June 4, 1974. Redesignated and amended at 55 FR 19859, May 
11, 1990]