BUPIVACAINE HYDROCHLORIDE (Page 8 of 8)

17 PATIENT COUNSELING INFORMATION

Allergic-Type Reactions

Assess if the patient has had allergic-type reactions to amide-type local anesthetics or to other formulation ingredients, such as the antimicrobial preservative methylparaben contained in multiple-dose vials or sulfites in epinephrine-containing solutions [see Contraindications (4), Warnings and Precautions (5.8), Adverse Reactions (6)].

Temporary Loss of Sensation and Motor Activity After Caudal or Epidural Anesthesia

When appropriate, patients should be informed in advance that they may experience temporary loss of sensation and motor activity, usually in the lower half of the body, following proper administration of caudal or epidural anesthesia.

Instructions After Dental Injection of Bupivacaine Hydrochloride Injection

Advise patients receiving dental injections of Bupivacaine Hydrochloride Injection not to chew solid foods or to test the anesthetized area by biting or probing until anesthesia has worn off (up to 7 hours) [see Warnings and Precautions (5.16)].

Methemoglobinemia

Inform patients that use of local anesthetics may cause methemoglobinemia, a serious condition that must be treated promptly. Advise patients or caregivers to seek immediate medical attention if they or someone in their care experience the following signs or symptoms: pale, gray, or blue colored skin (cyanosis); headache; rapid heart rate; shortness of breath; lightheadedness; or fatigue [see Warnings and Precautions (5.3)].

This product’s labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.

Distributed by Hospira, Inc., Lake Forest, IL 60045 USA

Novaplus is a registered trademark of Vizient, Inc.

LAB-1180-5.0

PRINCIPAL DISPLAY PANEL — 75 mg/30 mL Vial — 1159

NDC 0409-1159-09 Preservative-Free

0.25% Bupivacaine
Hydrochloride Injection, USP

75 mg/30 mL (2.5 mg/mL)

For INFILTRATION, NERVE BLOCK,
CAUDAL and EPIDURAL ANESTHESIA.

Not for spinal anesthesia.

LOT ##–###–AA
EXP DMMMYYYY

PRINCIPAL DISPLAY PANEL — 75 mg/30 mL Vial Tray — 1159

NDC 0409-1159-10
Contains 25 of NDC 0409-1159-09

30 mL Single-dose Teartop Vial
Preservative-Free
Rx only

0.25% Bupivacaine Hydrochloride
Injection, USP

75 mg/30 mL (2.5 mg/mL)

For INFILTRATION, NERVE BLOCK, CAUDAL and EPIDURAL ANESTHESIA.

Not for spinal anesthesia.

PRINCIPAL DISPLAY PANEL — 150 mg/30 mL Vial Label — 1162

NDC 0409-1162-09 Preservative-Free

0.5% Bupivacaine
Hydrochloride Injection, USP

150 mg/30 mL (5 mg/mL)

For NERVE BLOCK, CAUDAL and
EPIDURAL ANESTHESIA.

Not for spinal anesthesia.

LOT ##–###–AA
EXP DMMMYYYY

PRINCIPAL DISPLAY PANEL — 150 mg/30 mL Vial Tray — 1162

NDC 0409-1162-10
Contains 25 of NDC 0409-1162-09

30 mL Single-dose Teartop Vial
Preservative-Free
Rx only

0.5% Bupivacaine Hydrochloride
Injection, USP

150 mg/30 mL (5 mg/mL)

For NERVE BLOCK, CAUDAL and EPIDURAL ANESTHESIA.

Not for spinal anesthesia.

BUPIVACAINE HYDROCHLORIDE bupivacaine hydrochloride injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-1159 Route of Administration INFILTRATION, INTRACAUDAL, EPIDURAL, PERINEURAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BUPIVACAINE HYDROCHLORIDE (BUPIVACAINE) BUPIVACAINE HYDROCHLORIDE ANHYDROUS 2.5 mg in 1 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE 8.6 mg in 1 mL SODIUM HYDROXIDE HYDROCHLORIC ACID WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0409-1159-10 25 VIAL, SINGLE-DOSE in 1 TRAY contains a VIAL, SINGLE-DOSE (0409-1159-09) 1 NDC:0409-1159-09 30 mL in 1 VIAL, SINGLE-DOSE This package is contained within the TRAY (0409-1159-10)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA070583 08/11/2015

BUPIVACAINE HYDROCHLORIDE bupivacaine hydrochloride injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-1162 Route of Administration INTRACAUDAL, EPIDURAL, PERINEURAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BUPIVACAINE HYDROCHLORIDE (BUPIVACAINE) BUPIVACAINE HYDROCHLORIDE ANHYDROUS 5 mg in 1 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE 8.1 mg in 1 mL SODIUM HYDROXIDE HYDROCHLORIC ACID WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0409-1162-10 25 VIAL, SINGLE-DOSE in 1 TRAY contains a VIAL, SINGLE-DOSE (0409-1162-09) 1 NDC:0409-1162-09 30 mL in 1 VIAL, SINGLE-DOSE This package is contained within the TRAY (0409-1162-10)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA070584 02/07/2017

Labeler — Hospira, Inc. (141588017)

Establishment
Name	Address	ID/FEI	Operations
Hospira, Inc.		093132819	ANALYSIS (0409-1159), ANALYSIS (0409-1162), MANUFACTURE (0409-1159), MANUFACTURE (0409-1162), PACK (0409-1159), PACK (0409-1162), LABEL (0409-1159), LABEL (0409-1162)

Establishment
Name	Address	ID/FEI	Operations
Hospira, Inc.		827731089	ANALYSIS (0409-1159), ANALYSIS (0409-1162)

Establishment
Name	Address	ID/FEI	Operations
Pfizer Healthcare India Private Limited		860037912	ANALYSIS (0409-1159), ANALYSIS (0409-1162), MANUFACTURE (0409-1159), MANUFACTURE (0409-1162), PACK (0409-1159), PACK (0409-1162), LABEL (0409-1159), LABEL (0409-1162)

Revised: 03/2023 Hospira, Inc.