[Code of Federal Regulations]
[Title 21 Volume 5]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR331.30]

[Page 213-214]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 331--ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE--Table of Contents
 
                           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 Sec. 330.1(c)(2) of

[[Page 214]]

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 50 mEq. of magnesium in the 
recommended daily dosage: ``Do not use this product except under the 
advice and supervision of a physician if you have kidney disease.''
    (5) For products containing more than 25 mEq. potassium in the 
maximum recommended daily dose: ``Do not use this product except under 
the advice and supervision of a physician if you have kidney disease.''
    (6) 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.''
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    \1\ See Sec. 201.66(b)(4) of this chapter.
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    (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 Sec. 331.11(a), (b), and (d) through (m); permitted 
combinations of these ingredients provided for in Sec. 331.10; and any 
of these ingredients or combinations of these ingredients in combination 
with simethicone (identified in Sec. 332.10 of this chapter and provided 
for in Sec. 331.15(c)), are exempt from the requirement in Sec. 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 Sec. 331.11(k)(1), the 
labeling must continue to bear the first part of the general warning in 
Sec. 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.

[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]