Product Description.:
Suspension , white , bubble-gum
Ampicillin trihydrate is a semisynthetic penicillin derived from the basic penicillin nucleus, 6-aminopenicillanic acid. Ampicillin is designated chemically as (2S, 5R, 6R)-6-[(8)-2-Amino-2-phenylacetamido]-3,3-dimethyl-t-oxo-4-thia-1- azabicyclo[3.2.0] heptane-2-carboxylic acid.
PRINCIPEN Capsules (Ampicillin Capsules USP) for oral administration provide ampicillin trihydrate equivalent to 250 mg and 500 mg ampicillin.
Inactive ingredients: black iron oxide, gelatin, FD&C Blue #1, FD&C Red #3, FD&C Red #40, lactose monohydrate, silica gel, and titanium dioxide.
PRINCIPEN for Oral Suspension (Ampicillin for oral suspension USP) provide, after constitution, ampicillin trihydrate equivalent to 125 mg and 250 mg ampicillin per 5 mL.
Inactive ingredients: antifoam AF emulsion, Atmos 300, colloidal silicon dioxide, FD&C Red #40, lecithin, natural and artificial flavors, sucrose, sodium citrate, sodium benzoate, and vanillin.
INDICATIONS
PRINCIPEN Capsules (Ampicillin Capsules) and PRINCIPEN for Oral Suspension (Ampicillin for Oral Suspension) are indicated in the treatment of infections caused by susceptible strains of the designated organism listed below
Infections of the Genitourinary Tract Including Gonorrhea: E. coli, P. mirabilis, enterococci, Shigella, S. typhosa and other Salmonella, and nonpenicillinase-producing N. gononhoeae.
Infections of the Respiratory Tract: Nonpenicillinase-producing H. influenzae and staphylococci, and streptococci including streptococcus pneumoniae.
Infections of the Gastrointestinal Tract: Shigella, S. typhosa and other Salmonella, E. coli, P. mirabilis, and enterococci.
Meningitis: O. Meningitides.
Bacteriology studies to determine the causative organisms and their sensetivity to ampicillin should be performed. Therapy may be instituted prior to the results of susceptibility testing.
HOW SUPPLIED
PRINCIPEN Capsules (Ampicillin Capsules USP):
250 mg/capsule: Size 2 capsule with a light gray body and scarlet cap. Printed in black ink with BRISTOL 7902 on both body and cap.
bottles of 100 NDC 0003-0122-50
bottles of 500 NDC 0003-0122-60
Unimatic, unit dose packs of 100 NDC 0003-0122-51
500 mg/capsule: Size 0 capsule with a light gray body and scarlet cap. Printed in black ink with BRISTOL 7093 on both body and cap.
bottles of 100 NDC 0003-0134-50
bottles of 500 NDC 0003-0134-60
Unimatic, unit dose packs of 100 NDC 0003-0134-51
PRINCIPEN for Oral Suspension (Ampicillin for Oral Suspension USP):
Ampicilin 125: When constituted as directed on the container label, a pleasant fruit-flavored suspension containing: 125 mg per 6 mL, In bottle sizes for preparation of
100 mL NDC 0003-0969-09
150 mL NDC 0003-0969-52
200 mL NOC 0003-0969-61
Ampicilin 260: When constituted as directed on the container label, a pleasant fruit-flavored suspension containing: 250 mg per 5 mL, In bottle sizes for preparation of
100 mL NDC 0003-0972-52
200 mL NDC 0003-0972-61
Storage
Capsules: Store at room temperature avoid excessive heat keep tightly closed.
Ampicilin for oral suspension: Store at room temperature after constitution, discard unused portion after 7 days if kept at room temperature or after 14 days if refrigerated keep bottles tightly closed.
For Rx only
