NDC Code(s) : 43598-225-01, 43598-225-05, 43598-205-01, 43598-205-05, 43598-222-80, 43598-222-52, 43598-222-53, 43598-209-80, 43598-209-52, 43598-209-53
Packager : Dr Reddys Laboratories Inc
Category : HUMAN PRESCRIPTION DRUG LABEL
DEA Schedule : none
Marketing Status : New Drug Application
INGREDIENTS AND APPEARANCE
AMOXICILLINamoxicillin CAPSULE | ||||||||||||||||||||
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AMOXICILLINamoxicillin CAPSULE | ||||||||||||||||||||
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AMOXICILLINamoxicillin POWDER, FOR SUSPENSION | |||||||||||||||||||||||||
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AMOXICILLINamoxicillin POWDER, FOR SUSPENSION | |||||||||||||||||||||||||
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PRINCIPAL DISPLAY PANEL
NDC 43598-225-01
100 Capsules
AMOXICILLIN
CAPSULES
Each capsule contains 250 mg amoxicillin as the trihydrate.
250 mg
Rx Only
Use only if inner seal is intact.
Store at or below 25ºC (77ºF).
Dispense in a tight container.
Each capsule contains 250 mg amoxicillin as the trihydrate.
Usual Dosage: 250 to 500 mg every 8 hours.
See accompanying prescribing information.
Important:Use safety closures when dispensing this product unless otherwise directed by physician or requested by purchaser.
Manufactured. By: Dr. Reddy’s Laboratories Tennessee LLC.
Bristol, TN 37620
I0412
150039405
PRINCIPAL DISPLAY PANEL
NDC 43598-205-05
500 Capsules
AMOXICILLIN
CAPSULES
Each capsule contains 500 mg amoxicillin as the trihydrate.
500 mg
Rx Only
Use only if inner seal is intact.
Store at or below 25ºC (77ºF).
Dispense in a tight container.
Each capsule contains 500 mg amoxicillin as the trihydrate.
Usual Dosage: 250 to 500 mg every 8 hours.
See accompanying prescribing information.
Important:Use safety closures when dispensing this product unless otherwise directed by physician or requested by purchaser.
Manufactured. By: Dr. Reddy’s Laboratories Tennessee LLC.
Bristol, TN 37620
I0412
150039404
PRINCIPAL DISPLAY PANEL
NDC 43598-222-52
125 mg/5 mL
AMOXICILLIN
FOR ORAL SUSPENSION
When reconstituted, each 5 mL contains 125 mg amoxicillin as the trihydrate.
100 mL (when reconstituted)
Rx only
Directions for mixing:
Tap bottle until all powder flows freely. Add approximately 1/3 total amount of water for reconstitution (total = 78 mL) shake vigorously to wet powder. Add remaining water; again shake vigorously. Each 5 mL (1 teaspoonful) will contain amoxicillin trihydrate equivalent to 125 mg amoxicillin.
Usual Adult Dosage: 250 to 500 mg every 8 hours.
Usual Child Dosage: 20 to 40 mg/kg/day in divided doses every 8 hours, depending on age, weight and infection severity. See accompanying prescribing information.
Keep tightly closed.
Shake well before using.
Refrigeration preferable but not required.
Discard suspension after 14 days.
Use only if inner seal is intact.
Net contents: Equivalent to 2.5 grams amoxicillin.
Store dry powder at 20ºC-25ºC (68ºF-77ºF).
Manufactured. By: Dr. Reddy’s Laboratories Tennessee LLC.
Bristol, TN 37620
I0412
150039959
PRINCIPAL DISPLAY PANEL
NDC 43598-209-80
250 mg/5 mL
AMOXICILLIN
FOR ORAL SUSPENSION
When reconstituted, each 5 mL contains 250 mg amoxicillin as the trihydrate.
80 mL (when reconstituted)
Rx only
Directions for mixing:
Tap bottle until all powder flows freely. Add approximately 1/3 total amount of water for reconstitution (total = 59 mL); shake vigorously to wet powder. Add remaining water; again shake vigorously. Each 5 mL (1 teaspoonful) will contain amoxicillin trihydrate equivalent to 250 mg amoxicillin.
Usual Adult Dosage: 250 to 500 mg every 8 hours.
Usual Child Dosage: 20 to 40 mg/kg/day in divided doses every 8 hours, depending on age, weight and infection severity. See accompanying prescribing information.
Use only if inner seal is intact.
Net contents: Equivalent to 4.0 grams amoxicillin.
Store dry powder at 20ºC-25ºC (68ºF-77ºF).
Keep tightly closed. Shake well before using.
Refrigeration preferable but not required.
Discard suspension after 14 days.
Manufactured. By: Dr. Reddy’s Laboratories Tennessee LLC.
Bristol, TN 37620
I0512
150039961