NDC Code(s) : 63187-013-20, 63187-027-00
Packager : Proficient Rx LP

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

AMOXICILLINamoxicillin TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63187-013(NDC:43598-219)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMOXICILLIN(UNII: 804826J2HU)
(AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9) 		AMOXICILLIN ANHYDROUS875 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE (15 MPA.S AT 5%)(UNII: 68401960MK)
D&C RED NO. 30(UNII: 2S42T2808B)
HYPROMELLOSE 2910 (5 MPA.S)(UNII: R75537T0T4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color PINK Score 2 pieces
Shape CAPSULE Size 20 mm
Flavor Imprint Code AMOXIL;875
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63187-013-2020 in 1 BOTTLE Type 0: Not a Combination Product12/01/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050754 07/10/1978
AMOXICILLINamoxicillin POWDER, FOR SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63187-027(NDC:43598-207)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMOXICILLIN(UNII: 804826J2HU)
(AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9) 		AMOXICILLIN ANHYDROUS400 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM(UNII: 9NEZ333N27)0.19 meq in 5 mL
FD&C RED NO. 3(UNII: PN2ZH5LOQY)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM BENZOATE(UNII: OJ245FE5EU)
SODIUM CITRATE, UNSPECIFIED FORM(UNII: 1Q73Q2JULR)
SUCROSE(UNII: C151H8M554)
XANTHAN GUM(UNII: TTV12P4NEE)
Product Characteristics
Color Score
Shape Size
Flavor BUBBLE GUM Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63187-027-00100 mL in 1 BOTTLE Type 0: Not a Combination Product11/01/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050760 04/15/1999

LABELER - Proficient Rx LP(079196022)

Establishment
Name Address ID/FEI Business Operations
Proficient Rx LP 079196022 REPACK(63187-013, 63187-027), RELABEL(63187-013, 63187-027)

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL - PRINCIPLE DISPLAY PANEL

NDC 63187-013-20

20 Tablets

AMOXICILLIN

Tablets

Each Tablet contains 875 mg
amoxicillin as the trihydrate

Rx Only

Use only if inner seal is intact.
Store at or below 25°C (77°F). Dispense in a tight container.
Each tablet contains 875 mg amoxicillin as the trihydrate.

Usual Dosage: 1 tablet every 12 hours.
See accompanying prescribing information.

Important: Use safety closures when dispensing this product
unless otherwise directed by physician or requested by
purchaser.

63187-013-20

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL - PRINCIPLE DISPLAY PANEL

NDC 63187-027-00

400 mg/5 mL

AMOXICILLIN

FOR ORAL SUSPENSION

When reconstituted,
each 5mL contains
400 mg amoxicillin
as the trihydrate

Rx Only

Directions for mixing: Tap bottle until all powder flows freely.
Add approximately 1/3 total amount of water for reconstitution
(total=36 mL); shake vigorously to wet powder. Add remaining
water; again shake vigorously. Each 5 mL (1 teaspoonful) will
contain amoxicillin trihydrate equivalent to 400 mg amoxicillin.
Dosage: Administer every 12 hours.
See accompanying prescribing information.

Keep tightly closed.
Shake well before using.
Refrigeration preferable but not required.
Discard suspension after 14 days.

Net contents: Equivalent to 4.0 grams amoxicillin.
Store dry powder at or below 25°C (77°F).

63187-027-00