amoxicillin- Amoxicillin capsule amoxicillin- Amoxicillin tablet, film coated amoxicillin- Amoxicillin tablet, chewable amoxi

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

amoxicillin (UNII: 804826J2HU) (amoxicillin - UNII:804826J2HU)

Available from:

Ranbaxy Pharmaceutical Inc.

INN (International Name):

Amoxicillin

Pharmaceutical form:

CAPSULE

Composition:

250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) strains of the designated microorganisms in the conditions listed below: Infections of the ear, nose, and throat - due to Streptococcus spp. (α- and β-hemolytic strains only), S. pneumoniae , Staphylococcus spp., or H. influenzae. Infections of the genitourinary tract - due to E. coli, P. mirabilis, or E. faecalis. Infections of the skin and skin structure - due to Streptococcus spp. (α- and β-hemolytic strains only), Staphylococcus spp., or E. coli. Infections of the lower respiratory tract -due to Streptococcus spp. (α- and β-hemolytic strains only), S . pneumoniae, Staphylococcus spp., or H. influenzae . Gonorrhea, acute uncomplicated (ano-genital and urethral infections) - due to N. gonorrhoeae (males and females). H. pylori eradication to reduce the risk of duodenal ulcer recurrence Triple Therapy: Amoxicillin/clarithromycin/lansoprazole Amoxicillin, in combination with clarithromycin plu

Product summary:

Amoxicillin Capsules , USP : Each capsule contains 250 mg or 500 mg amoxicillin as the trihydrate. 250 mg Capsule 250 mg yellow opaque cap and yellow opaque body, size 2, printed “RX654” on both cap and body. NDC 63304-654-20 bottles of 20 NDC 63304-654-30 bottles of 30 NDC 63304-654-01 bottles of 100 NDC 63304-654-05 bottles of 500 NDC 63304-654-77 Unit-dose 100s 500 mg Capsule 500 mg maroon opaque cap and yellow opaque body, size 0-el, printed “RX655” on both cap and body. NDC 63304-762-82 bottles of 12 NDC 63304-762-20 bottles of 20 NDC 63304-762-01 bottles of 100 NDC 63304-762-13 bottles of 120 NDC 63304-762-05 bottles of 500 Amoxicillin Tablets , USP : Each tablet contains 500 mg or 875 mg amoxicillin as the trihydrate. 500 mg Tablet 500 mg pink colored, film coated, capsule shaped tablets; debossed with “RX762” on one side and plain on the other side. NDC 63304-762-82 bottles of 12 NDC 63304-762-20 bottles of 20 NDC 63304-762-01 bottles of 100 NDC 63304-762-13 bottles of 120 NDC 63304-762-05 bottles of 500 875 mg Tablet 875 mg pink colored, film coated, capsule shaped tablets; debossed with “RX763” on one side and scored on reverse side. NDC 63304-763-82 bottles of 12 NDC 63304-763-20 bottles of 20 NDC 63304-763-01 bottles of 100 NDC 63304-763-13 bottles of 120 NDC 63304-763-05 bottles of 500 Amoxicillin Chewable Tablets, USP: Each chewable tablet contains 125 mg, 200 mg, 250 mg or 400 mg amoxicillin as the trihydrate. 125 mg Tablet 125 mg pink colored, strawberry flavored, oval biconvex tablets, with mottled appearance; debossed with “RX514” on one side. NDC 63304-514-01 bottles of 100 NDC 63304-514-05 bottles of 500 200 mg Tablet 200 mg light pink colored, strawberry flavored, circular, flat faced, beveled edge tablets, with mottled appearance; debossed with “RX760” on one side. NDC 63304-760-20 bottles of 20 NDC 63304-760-01 bottles of 100 NDC 63304-760-05 bottles of 500 250 mg Tablet 250 mg pink colored, strawberry flavored, circular, flat faced, beveled edge tablets, with mottled appearance; debossed with “RX515” on one side. NDC 63304-515-30 bottles of 30 NDC 63304-515-01 bottles of 100 NDC 63304-515-04 bottles of 250 400 mg Tablet 400 mg light pink colored, strawberry flavored, circular, flat faced, beveled edge tablets, with mottled appearance; debossed with “RX716” on one side. NDC 63304-761-20 bottles of 20 NDC 63304-761-01 bottles of 100 NDC 63304-761-05 bottles of 500 Amoxicillin For Oral Suspension USP is available in: The 200 mg per 5 mL oral suspension* is off white to light orange granular powder forming a light orange to orange suspension on constitution with water. The resulting suspension has a characteristic fruity flavor and is available as follows: NDC 63304-969-03 50 mL bottles NDC 63304-969-01 75 mL bottles NDC 63304-969-04 100 mL bottles The 400 mg per 5 mL oral suspension* is off white to light orange granular powder forming a light orange to orange suspension* on constitution with water. The resulting suspension has a characteristic fruity flavor and is available as follows: NDC 63304-970-03 50 mL bottle NDC 63304-970-01 75 mL bottle NDC 63304-970-04 100 mL bottle *SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration preferable, but not required. Dispense in a tight container. Store amoxicillin capsules 250 mg and 500 mg,  amoxicillin tablets 500 mg and 875 mg, amoxicillin chewable tablets 125 mg, 200 mg, 250 mg and 400 mg and amoxicillin unreconstituted powder 200 mg/5 mL and 400 mg/5 mL at controlled room temperature 15° – 30° C (59° – 86° F) (see USP).

Summary of Product characteristics

AMOXICILLIN- AMOXICILLIN CAPSULE
AMOXICILLIN- AMOXICILLIN TABLET, FILM COATED
AMOXICILLIN- AMOXICILLIN TABLET, CHEWABLE
AMOXICILLIN- AMOXICILLIN SUSPENSION
RANBAXY PHARMACEUTICAL INC.
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RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of amoxicillin
capsules, amoxicillin tablets, amoxicillin tablets (chewable) and
amoxicillin for oral suspension and
other antibacterial drugs, amoxicillin capsules, amoxicillin tablets,
amoxicillin tablets (chewable) and
amoxicillin for oral suspension should be used only to treat or
prevent infections that are proven or
strongly suspected to be caused by bacteria.
DESCRIPTION
Amoxicillin formulations contain amoxicillin, a semisynthetic
antibiotic, an analog of ampicillin, with a
broad spectrum of bactericidal activity against many gram-positive and
gram-negative microorganisms.
Chemically it is (2_S_,5_R_,6_R_)-6-[(_R_)-(-)-2-
amino-2-(_p_-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-
thia-1-azabicyclo[3.2.0] heptane-2-carboxylic acid trihydrate. It may
be represented structurally as:
The amoxicillin molecular formula is C
H N O S•3H O, and the molecular weight is 419.45.
Amoxicillin capsules, tablets, and oral suspension are intended for
oral administration.
CAPSULES: Each amoxicillin capsule contains amoxicillin trihydrate
equivalent to amoxicillin anhydrous
250 mg or 500 mg. Inactive ingredients: black iron oxide, colloidal
silicon dioxide, croscarmellose
sodium, D&C Yellow No. 10, FD&C Yellow No. 6, gelatin, magnesium
stearate, microcrystalline
cellulose, shellac, sodium lauryl sulfate and titanium dioxide. In
addition 250 mg capsule contains
FD&C Red No. 40 and 500 mg capsule contains D&C Red No. 28 and FD&C
Blue No. 1.
TABLETS: Each amoxicillin tablet contains amoxicillin trihydrate
equivalent to amoxicillin anhydrous 500
mg or 875 mg. Inactive ingredients: colloidal silicon dioxide,
crospovidone, D&C Red No. 30
aluminum lake, hypromellose, magnesium stearate, microcrystalline
cellulose, polyethylene glycol,
sodium star