• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

  • Print
  • Share
  • E-mail
-

The information on this page is current as of April 1 2019.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

New Search
Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2019]
[CITE: 21CFR331]





TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER D--DRUGS FOR HUMAN USE
 
PART 331ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE
 

Subpart D--Labeling

Sec. 331.30 Labeling of antacid products.

(a) Statement of identity. The labeling of the product contains the established name of the drug, if any, and identifies the product as an "antacid."

(b) Indications. The labeling of the product states, under the heading "Indications," the following: "For the relief of" (optional, any or all of the following:) "heartburn," "sour stomach," and/or "acid indigestion" (which may be followed by the optional statement:) "and upset stomach associated with" (optional, as appropriate) "this symptom" or "these symptoms." Other truthful and nonmisleading statements, describing only the indications for use that have been established and listed in this paragraph (b), may also be used, as provided in 330.1(c)(2) of this chapter, subject to the provisions of section 502 of the act relating to misbranding and the prohibition in section 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act.

(c) Warnings. The labeling of the product contains the following warnings, under the heading "Warnings", which may be combined but not rearranged to eliminate duplicative words or phrases if the resulting warning is clear and understandable:

(1) "Do not take more than (maximum recommended daily dosage, broken down by age groups if appropriate, expressed in units such as tablets or teaspoonfuls) in a 24-hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a physician."

(2) For products which cause constipation in 5 percent or more of persons who take the maximum recommended dosage: "May cause constipation."

(3) For products which cause laxation in 5 percent or more of persons who take the maximum recommended dosage: "May have laxative effect."

(4) For products containing more than 5 gm per day lactose in a maximum daily dosage: "Do not use this product except under advice and supervision of a physician if you are allergic to milk or milk products."

(d) Drug interaction precaution. The labeling of the product contains the following statement "Ask a doctor or pharmacist before use if you are [bullet] 1 presently taking a prescription drug. Antacids may interact with certain prescription drugs."

(e) Directions for use. The labeling of the product contains the recommended dosage, under the heading "Directions", per time interval (e.g., every 4 hours) or time period (e.g., 4 times a day) broken down by age groups if appropriate, followed by "or as directed by a physician."

(f) Exemption from the general accidental overdose warning. The labeling for antacid drug products containing the active ingredients identified in 331.11(a), (b), and (d) through (m); permitted combinations of these ingredients provided for in 331.10; and any of these ingredients or combinations of these ingredients in combination with simethicone (identified in 332.10 of this chapter and provided for in 331.15(c)), are exempt from the requirement in 330.1(g) of this chapter that the labeling bear the general warning statement "In case of accidental overdose, seek professional assistance or contact a poison control center immediately." With the exception of sodium bicarbonate powder products identified in 331.11(k)(1), the labeling must continue to bear the first part of the general warning in 330.1(g) of this chapter, which states, "Keep this and all drugs out of the reach of children."

(g) [Reserved]

(h) The word "doctor" may be substituted for the word "physician" in any of the labeling statements in this section.

1See 201.66(b)(4) of this chapter.

[39 FR 19874, June 4, 1974, as amended at 47 FR 38484, Aug. 31, 1982; 51 FR 16266, May 1, 1986; 51 FR 27763, Aug. 1, 1986; 52 FR 7830, Mar. 13, 1987; 55 FR 11581, Mar. 29, 1990; 58 FR 45208, Aug. 26, 1993; 59 FR 60556, Nov. 25, 1994; 61 FR 17806, Apr. 22, 1996; 64 FR 13295, Mar. 17, 1999; 69 FR 13734, Mar. 24, 2004]

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 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 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.

(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]

Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.
Source: 39 FR 19874, June 4, 1974, unless otherwise noted.

-
-