Buying flagyl 500 mg tablets each containing 50 mg of paroxetine hydrobromide tablet from the manufacturer of brand name 100 mg tablets; and
(B) A written statement, on the labeling of label generic version the active ingredient of brand name 100 mg tablets and the label of tag brand 100 mg tablets, Flagyl er $0.56 - pills Per pill showing the name and strength of active ingredient the brand name 100 mg tablets.
The labeling of tag brand 100 mg tablets shall include:
(1) Information similar to that required on the label of a brand name 100 mg tablet for which a drug equivalency statement has been approved by the Food and Drug Administration;
(2) A statement on the label of tag brand 100 mg tablets that shows paroxetine hydrobromide tablet is a narcotic under 21 U.S.C. 802(a) and its Controlled Substances Act, 21 CFR part 530;
(3) A statement on the label of tag brand 100 mg tablets advising that the inactive ingredient in active tag brand 100 mg tablets is a synthetic diuretic and that paroxetine hydrobromide tablet is contraindicated in a patient with renal failure; and
(4) A statement on the label of tag brand 100 mg tablets, in an easily understood and conspicuous manner, that the tag brand 100 mg tablets contain oxycodone base and that paroxetine hydrobromide tablet should be used with caution by patients chronic pain, heart failure, congestive stroke, a history of kidney and liver damage, or a current psychiatric disorder, and in pediatric patients 6 to 12 years of age.
(d) The active ingredient in tag brand 100 mg tablets is oxycodone base, U.S.P.
(e) The active ingredient in tag brand 100 mg tablets is paroxetine hydrobromide, U.S.P.
(f) The brand name and tag 100 mg tablets will contain the same active ingredients as shown in paragraph (f) of this section and have the same active ingredient concentration as shown in paragraph (d) of this section.
[42 FR 24008, Dec. 13, 1977]
§16.122 Description of label requirements.
Not later than 12 months after May 10, 1988, the provisions of §16.105(b) this chapter and the amendments made by Public Law 99-591 (100 Stat. 2637) under the Federal Food, Drug, and Cosmetic Act shall apply to any drugs, biological products, or other products that are being or shall be marketed as containing a prescription drug listed in schedule C or CII of part 16.2 this subchapter or a biological product that is to be marketed as containing a prescription drug Best drugstore brand retinol listed in schedule V or VII of part 16.2 this subchapter.
[42 FR 37535, July 10, 1977]
Section IX. Drug Safety Monitoring
§16.124 Drug Safety Monitor.
(a) Designated Agency. The Drug Safety and Risk Management Agency (DSM)
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