(a)Specifications. Each milliliter of the drug contains 11.36 mg of doxylamine succinate.
(b)Sponsor. See No. 000061 in § 510.600(c) of this chapter.
(c)Conditions of use.
(1) The drug is used in conditions in which antihistaminic therapy may be expected to alleviate some signs of disease in horses, dogs, and cats. 1
1 These conditions are NAS/NRC reviewed and deemed effective. Applications for these uses need not include effectiveness data as specified by § 514.111 of this chapter.
(2) It is administered to horses at a dosage level of 25 mg per hundred pounds of body weight. It is administered to dogs and cats at a dosage level of 0.5 to 1 mg per pound of body weight. Doses may be repeated at 8 to 12 hours, if necessary, to produce desired effect. Intravenous route is not recommended for dogs and cats and should be injected slowly in horses. Intramuscular and subcutaneous administration should be by divided injection sites. 1
(3) Not for use in horses intended for food. 1
(4) Federal law restricts this drug to use by or on the order of a licensed veterinarian. 1
[40 FR 13858, Mar. 27, 1975, as amended at 42 FR 60140, Nov. 25, 1977; 46 FR 48642, Oct. 2, 1981; 61 FR 8873, Mar. 6, 1996; 62 FR 61625, Nov. 19, 1997]
Title 21 published on 2014-04-01
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