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 | ||||||||||||||||||||||
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AMOXICILLINamoxicillin POWDER, FOR SUSPENSION | ||||||||||||||||||
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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.
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).