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Legal Resources | Code of Federal Regulations, Title 21 |    1308.22, 1308.022  

Excluded substances.   

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The following nonnarcotic substances which may, under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301), be lawfully sold over the counter without a prescription, are excluded from all schedules pursuant to section 201(g) (1) of the Act (21 U.S.C. 811(g) (1)):

Excluded Nonnarcotic Products ----------------------------------------------

Controlled (mg or mg/

Company Trade name NDC code Form substance ml) ---------------------------------------------------------------------------------------------------------------- Bioline Laboratories........... Theophed.......... 00719-1945 TB Phenobarbital..... 8.00 Goldline Laboratories.......... Guiaphed Elixir... 00182-1377 EL Phenobarbital..... 4.00 Goldline Laboratories.......... Tedrigen Tablets.. 00182-0134 TB Phenobarbital..... 8.00 Hawthorne Products Inc......... Choate's Leg .............. LQ Chloral hydrate... 246.67

Freeze. Parke-Davis & Co............... Tedral............ 00071-0230 TB Phenobarbital..... 8.00 Parke-Davis & Co............... Tedral Elixir..... 00071-0242 EX Phenobarbital..... 40.00 Parke-Davis & Co............... Tedral S.A........ 00071-0231 TB Phenobarbital..... 8.00 Parke-Davis & Co............... Tedral Suspension. 00071-0237 SU Phenobarbital..... 80.00 Parmed Pharmacy................ Asma-Ese.......... 00349-2018 TB Phenobarbital..... 8.10 Rondex Labs.................... Azma-Aids......... 00367-3153 TB Phenobarbital..... 8.00 Smith Kline Consumer........... Benzedrex......... 49692-0928 IN Propylhexedrine... 250.00 Sterling Drug, Inc............. Bronkolixir....... 00057-1004 EL Phenobarbital..... 0.80 Sterling Drug, Inc............. Bronkotabs........ 00057-1005 TB Phenobarbital..... 8.00 Vicks Chemical Co.............. Vicks Inhaler..... 23900-0010 IN I-Desoxyephedrine. 113.00 White Hall Labs................ Primatene (P- 00573-2940 TB Phenobarbital..... 8.00

tablets). ----------------------------------------------------------------------------------------------------------------

[38 FR 8255, Mar. 30, 1973. Redesignated at 38 FR 26609, Sept. 24, l973, and amended at 41 FR 16553, Apr. 20, 1976; 41 FR 53477, Dec. 7, 1976; 46 FR 51603, Oct. 21, 1981; 47 FR 45867, Oct. 14, 1982; 54 FR 2100, Jan. 19, 1989; 55 FR 12162, Mar. 30, 1990; 62 FR 13968, Mar. 24, 1997]