# 522.88 Amoxicillin.
(a) *Specifications.* (1) Each vial contains 3 grams (g) of amoxicillin trihydrate. Each milliliter of constituted suspension contains 100 or 250 milligrams (mg) amoxicillin trihydrate for use as in paragraph (d)(1) of this section.
(2) Each vial contains 25 g of amoxicillin trihydrate. Each milliliter of constituted suspension contains 250 mg amoxicillin trihydrate for use as in paragraph (d)(2) of this section.
(b) *Sponsor.* See No. 054771 in § 510.600(c) of this chapter.
(c) *Related tolerance.* See § 556.38 of this chapter.
(d) *Conditions of use*—(1) *Dogs and cats*—(i) *Amount.* Administer 5 mg per pound of body weight daily for up to 5 days by intramuscular or subcutaneous injection.
(ii) *Indications for use*—(A) *Dogs.* For treatment of infections caused by susceptible strains of organisms as follows: Respiratory infections (tonsillitis, tracheobronchitis) due to *Staphylococcus aureus, Streptococcus* spp., *Escherichia coli,* and *Proteus mirabilis;* genitourinary infections (cystitis) due to *S. aureus, Streptococcus* spp., *E. coli,* and *P. mirabilis;* gastrointestinal infections (bacterial gastroenteritis) due to *S. aureus, Streptococcus* spp., *E. coli,* and *P. mirabilis;* bacterial dermatitis due to *S. aureus, Streptococcus* spp., and *P. mirabilis;* soft tissue infections (abscesses, lacerations, and wounds), due to *S. aureus, Streptococcus* spp., *E. coli,* and *P. mirabilis.*
(B) *Cats.* For treatment of infections caused by susceptible strains of organisms as follows: Upper respiratory infections due to *S. aureus, Staphylococcus* spp., *Streptococcus* spp., *Haemophilus* spp., *E. coli, Pasteurella* spp., and *P. mirabilis;* genitourinary infections (cystitis) due to *S. aureus, Streptococcus* spp., *E. coli, P. mirabilis,* and *Corynebacterium* spp.; gastrointestinal infections due to *E. coli, Proteus* spp., *Staphylococcus* spp., and *Streptococcus* spp.; skin and soft tissue infections (abscesses, lacerations, and wounds) due to *S. aureus, Staphylococcus* spp., *Streptococcus* spp., *E. coli,* and *Pasteurella multocida.*
(iii) *Limitations.* Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) *Cattle*—(i) *Amount.* Administer 3 to 5 mg per pound of body weight daily for up to 5 days by intramuscular or subcutaneous injection.
(ii) *Indications for use.* For treatment of diseases due to amoxicillin-susceptible organisms as follows: Respiratory tract infections (shipping fever, pneumonia) due to *P. multocida,* *P. hemolytica, Haemophilus* spp., *Staphylococcus* spp., and *Streptococcus* spp. and acute necrotic pododermatitis (foot rot) due to *Fusobacterium necrophorum.*
(iii) *Limitations.* Treated animals must not be slaughtered for food during treatment and for 25 days after the last treatment. Milk from treated cows must not be used for human consumption during treatment or for 96 hours (8 milkings) after last treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[79 FR 16183, Mar. 25, 2014]