21 C.F.R. § 1308.22   Excluded substances.


Title 21 - Food and Drugs


Title 21: Food and Drugs
PART 1308—SCHEDULES OF CONTROLLED SUBSTANCES
Excluded Nonnarcotic Substances

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§ 1308.22   Excluded substances.

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.....         8.00Goldline Laboratories..........  Guiaphed Elixir...      00182-1377  EL          Phenobarbital.....         4.00Goldline Laboratories..........  Tedrigen Tablets..      00182-0134  TB          Phenobarbital.....         8.00Hawthorne Products Inc.........  Choate's Leg        ..............  LQ          Chloral hydrate...       246.67                                  Freeze.Parke-Davis & Co...........  Tedral............      00071-0230  TB          Phenobarbital.....         8.00Parke-Davis & Co...........  Tedral Elixir.....      00071-0242  EX          Phenobarbital.....        40.00Parke-Davis & Co...........  Tedral S.A........      00071-0231  TB          Phenobarbital.....         8.00Parke-Davis & Co...........  Tedral Suspension.      00071-0237  SU          Phenobarbital.....        80.00Parmed Pharmacy................  Asma-Ese..........      00349-2018  TB          Phenobarbital.....         8.10Rondex Labs....................  Azma-Aids.........      00367-3153  TB          Phenobarbital.....         8.00Smith Kline Consumer...........  Benzedrex.........      49692-0928  IN          Propylhexedrine...       250.00Sterling Drug, Inc.............  Bronkolixir.......      00057-1004  EL          Phenobarbital.....         0.80Sterling Drug, Inc.............  Bronkotabs........      00057-1005  TB          Phenobarbital.....         8.00Vicks Chemical Co..............  Vicks Inhaler.....      23900-0010  IN          I-Desoxyephedrine.       113.00White Hall Labs................  Primatene (P-           00573-2940  TB          Phenobarbital.....         8.00                                  tablets).----------------------------------------------------------------------------------------------------------------

[38 FR 8255, Mar. 30, 1973. Redesignated at 38 FR 26609, Sept. 24, 1973, 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]

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