StacksVerified U.S. regulatory reference

21 CFR §520.980

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (a)Specifications. Each chewable tablet contains 8, 16, 32, or 64 milligrams (mg) fluoxetine hydrochloride.
  2. (b)Sponsor. See No. 055246 in § 510.600 of this chapter.
  3. (c)Conditions of use in dogs—(1) Amount. 1 to 2 mg per kilogram body weight once daily.
    1. (2)Indications for use. For the treatment of canine separation anxiety in conjunction with a behavior modification plan.
    2. (3)Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.