Acetaminophen and Codeine Phosphate (Page 11 of 11)

Package/Label Display Panel

AKORN

Acetaminophen and Codeine Phosphate Oral Solution, USP

120 mg/12 mg per 5 mL

Rx only

This is a bulk container. Not intended for household use.

Each 5 mL (teaspoonful) contains:

Acetaminophen …………………………………………… 120 mg

Codeine * Phosphate ………………………………………. 12 mg

Alcohol ………………………………………………………. 7%

*WARNING: May be habit-forming.

Protect from light.

Inactive Ingredients: artificial cherry flavor, citric acid, FD&C Yellow No. 6, propylene glycol, purified water, saccharin sodium, sodium benzoate, and sucrose.

Usual Dosage:

Adults: 15 mL (1 tablespoon) every four hours as needed.

Store at 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

Protect from light. Do not refrigerate.

Dispense in a tight, light-resistant container as defined in the official compendium.

CAP HAS A PRINTED SAFETY SEAL AROUND THE NECK. DO NOT ACCEPT IF BROKEN OR MISSING.

16 FL OZ (473 mL)

Package/Label Display Panel

Delivers 5 mL

NDC 50383-337-05

Acetaminophen and Codeine Phosphate Oral Solution, USP CV

120 mg/12 mg per 5 mL (24 mg/2.4 mg per mL) and Alcohol 7%

FOR INSTITUTIONAL USE ONLY

Store at 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

Protect from light. Do not refrigerate.

See insert for full prescribing information.

Rx only

Package/Label Display Panel

Delivers 10 mL

NDC 50383-338-10

Acetaminophen and Codeine Phosphate Oral Solution, USP CV

240 mg/24 mg per 10 mL (24 mg/2.4 mg per mL) and Alcohol 7%

FOR INSTITUTIONAL USE ONLY

Store at 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

Protect from light. Do not refrigerated.

See insert for full prescribing information.

Rx only

Package/Label Display Panel

Delivers 12.5 mL

NDC 50383-339-12

Acetaminophen and Codeine Phosphate Oral Solution, USP CV

300 mg/30 mg per 12.5 mL (24 mg/2.4 mg per mL) and Alcohol 7%

FOR INSTITUTIONAL USE ONLY

Store at 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

Protect from light. Do not refrigerate.

See insert for full prescribing information.

Rx only

Package/Label Display Panel

Delivers 15 mL

NDC 50383-340-15

Acetaminophen and Codeine Phosphate Oral Solution, USP CV

360 mg/36 mg per 15 mL (24 mg/2.4 mg per mL) and Alcohol 7%

FOR INSTITUTIONAL USE ONLY

Store at 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

Protect from light. Do not refrigerated.

See insert for full prescribing information.

Rx only

ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen and codeine phosphate solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50383-079 Route of Administration ORAL DEA Schedule CV

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 120 mg in 5 mL CODEINE PHOSPHATE (CODEINE ANHYDROUS) CODEINE PHOSPHATE 12 mg in 5 mL

Inactive Ingredients Ingredient Name Strength ALCOHOL ANHYDROUS CITRIC ACID CHERRY FD&C YELLOW NO. 6 PROPYLENE GLYCOL SACCHARIN SODIUM SODIUM BENZOATE SUCROSE WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:50383-079-16 473 mL in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040119 04/26/1996

ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen and codeine phosphate solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50383-337 Route of Administration ORAL DEA Schedule CV

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 120 mg in 5 mL CODEINE PHOSPHATE (CODEINE ANHYDROUS) CODEINE PHOSPHATE 12 mg in 5 mL

Inactive Ingredients Ingredient Name Strength ALCOHOL ANHYDROUS CITRIC ACID CHERRY FD&C YELLOW NO. 6 PROPYLENE GLYCOL SACCHARIN SODIUM SODIUM BENZOATE SUCROSE WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:50383-337-06 4 TRAY in 1 CASE contains a TRAY 1 10 CUP, UNIT-DOSE in 1 TRAY This package is contained within the CASE (50383-337-06) and contains a CUP, UNIT-DOSE (50383-337-05) 1 NDC:50383-337-05 5 mL in 1 CUP, UNIT-DOSE This package is contained within a TRAY and a CASE (50383-337-06)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040119 04/26/1996

ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen and codeine phosphate solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50383-338 Route of Administration ORAL DEA Schedule CV

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 240 mg in 10 mL CODEINE PHOSPHATE (CODEINE ANHYDROUS) CODEINE PHOSPHATE 24 mg in 10 mL

Inactive Ingredients Ingredient Name Strength ALCOHOL ANHYDROUS CITRIC ACID CHERRY FD&C YELLOW NO. 6 PROPYLENE GLYCOL SACCHARIN SODIUM SODIUM BENZOATE SUCROSE WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:50383-338-11 4 TRAY in 1 CASE contains a TRAY 1 10 CUP, UNIT-DOSE in 1 TRAY This package is contained within the CASE (50383-338-11) and contains a CUP, UNIT-DOSE (50383-338-10) 1 NDC:50383-338-10 10 mL in 1 CUP, UNIT-DOSE This package is contained within a TRAY and a CASE (50383-338-11)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040119 04/26/1996

ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen and codeine phosphate solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50383-339 Route of Administration ORAL DEA Schedule CV

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 300 mg in 12.5 mL CODEINE PHOSPHATE (CODEINE ANHYDROUS) CODEINE PHOSPHATE 30 mg in 12.5 mL

Inactive Ingredients Ingredient Name Strength ALCOHOL ANHYDROUS CITRIC ACID CHERRY FD&C YELLOW NO. 6 PROPYLENE GLYCOL SACCHARIN SODIUM SODIUM BENZOATE SUCROSE WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:50383-339-13 4 TRAY in 1 CASE contains a TRAY 1 10 CUP, UNIT-DOSE in 1 TRAY This package is contained within the CASE (50383-339-13) and contains a CUP, UNIT-DOSE (50383-339-12) 1 NDC:50383-339-12 12.5 mL in 1 CUP, UNIT-DOSE This package is contained within a TRAY and a CASE (50383-339-13)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040119 04/26/1996

ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen and codeine phosphate solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50383-340 Route of Administration ORAL DEA Schedule CV

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 360 mg in 15 mL CODEINE PHOSPHATE (CODEINE ANHYDROUS) CODEINE PHOSPHATE 36 mg in 15 mL

Inactive Ingredients Ingredient Name Strength ALCOHOL ANHYDROUS CITRIC ACID CHERRY FD&C YELLOW NO. 6 PROPYLENE GLYCOL SACCHARIN SODIUM SODIUM BENZOATE SUCROSE WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:50383-340-17 4 TRAY in 1 CASE contains a TRAY 1 10 CUP, UNIT-DOSE in 1 TRAY This package is contained within the CASE (50383-340-17) and contains a CUP, UNIT-DOSE (50383-340-15) 1 NDC:50383-340-15 15 mL in 1 CUP, UNIT-DOSE This package is contained within a TRAY and a CASE (50383-340-17)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040119 04/26/1996

Labeler — Akorn (117696873)

Registrant — Akorn Operating Company LLC (117693100)

Establishment
Name	Address	ID/FEI	Operations
Akorn		117696873	MANUFACTURE (50383-079), MANUFACTURE (50383-337), MANUFACTURE (50383-338), MANUFACTURE (50383-339), MANUFACTURE (50383-340), PACK (50383-079), PACK (50383-337), PACK (50383-338), PACK (50383-339), PACK (50383-340)

Revised: 11/2022 Akorn