ANSWERS
06/19/1995

<TITLE>CIMETIDINE CLEARED FOR MARKETING AS OVER-THE-COUNTER HEARTBURN MEDICATION</TITLE>
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T95-27                                            Ivy F. Kupec
June 19, 1995                                     (301) 443-3285

CIMETIDINE CLEARED FOR MARKETING 
AS OVER-THE-COUNTER HEARTBURN MEDICATION

     FDA has been receiving inquiries about the clearance of
Tagamet HB (cimetidine) tablets for over-the-counter marketing to
treat episodic heartburn.  They have been available by
prescription since 1977 to treat ulcers and other
gastrointestinal illnesses.  Medical experts estimate that 50
million people in the United States suffer from heartburn.
     Tagamet HB is the second drug of its class to enter the
over-the-counter drug market. Pepcid AC Acid Controller was
cleared for marketing on April 28 of this year.  Antacids, which
neutralize existing stomach acid, are also available over the
counter to treat heartburn.  Tagamet HB, like Pepcid AC Acid
Controller, reduces the amount of stomach acid produced.  
     Tagamet HB will be marketed in 100 mg tablets to relieve
symptoms of occasional heartburn, acid indigestion and sour
stomach in people age 12 and older.  No more than 400 mg should
be taken in 24 hours, and Tagamet HB should be taken for no more
than two weeks at the maximum dose without consulting a doctor. 
Before taking Tagamet HB, consumers also are advised to consult
their doctor if they have been prescribed theophylline (oral 
                             -MORE-

                                         Page 2, T95-27, Tagamet
asthma medicine), warfarin (blood-thinning medicine) or phenytoin
(seizure medicine).  If consumers are unsure whether their
medicines contain one of these drugs or have questions about how
their other medications will interact with Tagamet HB, they
should call SmithKline Beecham Consumer Affairs at 1-800-482-
4394. 
     Consumers should see a doctor if they have trouble
swallowing or suffer persistent abdominal pain, as these symptoms
may indicate a more serious condition.
     The product will be distributed by SmithKline Beecham PLC of
Philadelphia.
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