ATROPINE SULFATE INJECTABLE SOLUTION

Manufacturer
Sparhawk Laboratories, Inc
Effective date
2015-04-20
Label type
PRESCRIPTION ANIMAL DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:39:53

Label at a glance#

ProductATROPINE SULFATE
Active ingredientATROPINE SULFATE
Label structure6 sections

Dosage and administration

Dogs and Cats :  Inject intravenously, intramuscularly, or subcutaneously, 1 mL for each 20 lbs of body weight as a preanesthetic adjuvant, or to reudce salivation, bronchial secretions, or intestinal peristalsis associated with colic or diarrhea.  As an antidote for parasympathomimetic drugs, inject 1 mL for each 5 lbs of body weight administered to effect and repeat as necessary.  It is suggested that 1/4 of the...

Storage and handling

Store at controlled room temperature between 15 o and 30 o C (59 o -86 o F) PROTECT FROM LIGHT TAKE TIME OBSERVE LABEL DIRECTIONS

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

(0.54 mg/mL)

FOR ANIMAL USE ONLY

KEEP OUT OF REACH OF CHILDREN

CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.


INDICATIONS

For use in Dogs and Cats as an antidote in the treatment of organophosphate insecticide poisoning; to reduce salivation, bronchial secretions or intestinal peristalsis associated with colic or diarrhea, and as a preanesthetic adjuvant.

DOSAGE AND ADMINISTRATION:

DOSAGE & ADMINISTRATION SECTION

Dogs and Cats:  Inject intravenously, intramuscularly, or subcutaneously, 1 mL for each 20 lbs of body weight as a preanesthetic adjuvant, or to reudce salivation, bronchial secretions, or intestinal peristalsis associated with colic or diarrhea. 

As an antidote for parasympathomimetic drugs, inject 1 mL for each 5 lbs of body weight administered to effect and repeat as necessary.  It is suggested that 1/4 of the dosage be injected intravenously and the remainder intramuscularly or subcutaneously.

WARNING

WARNINGS SECTION

Poisonous alkaloid.

Antidotes:  Warmth, Emetics, Cholinergics

COMPOSITION

DESCRIPTION SECTION

Each mL of sterile solution contains:


Atropine Sulfate  ............................  0.54 mg
Sodium Chloride .................................  9 mg
Benzyl Alcohol  ..................................  1.5%
Water for Injection  ................................  QS

STORAGE AND HANDLING SECTION

Store at controlled room temperature between 15o and 30oC (59o-86oF)

PROTECT FROM LIGHT

TAKE TIME OBSERVE LABEL DIRECTIONS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SLI Atropine Sulfate SA labelSLI Atropine Sulfate SA label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1145629atropine sulfate 0.54 MG/ML Injectable SolutionPSN2
1145629atropine sulfate 0.54 MG/ML Injectable SolutionSCD2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ATROPINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c78bd43-efb4-4aeb-b7d8-eff1532f7822Product name420250801
41231c1e-8789-4da7-ac52-77fa90a85bf5Product name220250304
e77ab9a2-80cf-4832-bff0-469bbc7cbcd0Product name220250214
5f84b7a7-523a-f042-dffb-1dadcd9b2407Product name420240110
0cbc6fb2-78c0-4b88-98f0-a4cc76ff95caProduct name120230719
04cd5dc0-102f-46cb-8dbc-ca38dd2628d0Product name320230317
dfd25202-b8d2-4628-9213-f3e0f9eafce5Product name420210513
4199bf9b-4718-828a-6dd6-ac2fbbd61687Product name120140508
4edd8af5-cea7-ae42-8023-e91c5335db1dProduct name120140508
d3908afb-7784-440f-c406-88294732d36aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58005-354-04ATROPINE SULFATE100 mL in 1 VIALINJECTION, SOLUTION1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58005-354ATROPINE SULFATE INJECTION, SOLUTION [SPARHAWK LABORATORIES, INC]21 package rows20150422_408c06b2-4f96-4ea2-9d33-2b148fd01884.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ATROPINE SULFATEACTIVE INGREDIENT03J5ZE7KA52
ATROPINEACTIVE MOIETY7C0697DR9I2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58005-35458005-354-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
ATROPINE SULFATE03J5ZE7KA5ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 3 · 59 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Atropine SulfateATROPINE SULFATEREMEDYREPACK INC.8663ff94-8bea-4061-9fd5-3ab2e85e862e2026-09-04Warnings, Adverse reactionsName fallback
brand name: Atropine Sulfate
generic name: ATROPINE SULFATE
Atropine SulfateATROPINE SULFATEREMEDYREPACK INC.532aa441-92ec-42d6-862a-639f8cfe99512026-08-31Warnings, Adverse reactionsName fallback
brand name: Atropine Sulfate
generic name: ATROPINE SULFATE
AtropineATROPINE SULFATEGland Pharma Limiteda116af5c-ba4c-408c-9a02-4bc33772aa8d2026-08-03Warnings, Adverse reactionsName fallback
generic name: ATROPINE SULFATE
Atropine SulfateATROPINE SULFATEHenry Schein, Inc.0f5b0961-efe7-42c3-898e-2f7fc7fc90b12026-07-28Warnings, Adverse reactionsName fallback
brand name: Atropine Sulfate
generic name: ATROPINE SULFATE
ATROPINE SULFATEATROPINE SULFATEHF Acquisition Co LLC, DBA HealthFirst768dc21a-b7d9-144c-e053-2991aa0af8892026-06-19Warnings, Adverse reactionsName fallback
brand name: ATROPINE SULFATE
generic name: ATROPINE SULFATE
Atropine SulfateATROPINE SULFATEHospira, Inc.ad8916e7-206e-409e-2582-30d072845dd42026-05-18Warnings, Adverse reactionsName fallback
brand name: Atropine Sulfate
generic name: ATROPINE SULFATE
Atropine sulfateATROPINE SULFATEEdenbridge Pharmaceuticals LLC.b39f5876-5d6f-4a8f-bd24-bd4be24ff5682026-05-07Warnings, Adverse reactionsName fallback
brand name: Atropine sulfate
generic name: ATROPINE SULFATE
Atropine SulfateATROPINE SULFATEREMEDYREPACK INC.46ba6000-b842-449a-8dd4-7bb9dc7a74c52026-04-03Warnings, Adverse reactionsName fallback
brand name: Atropine Sulfate
generic name: ATROPINE SULFATE
atropine sulfateATROPINE SULFATEAlcon Laboratories, Inc.c8093125-ed1a-4eb6-9c81-52c5c73764812026-03-13Warnings, Adverse reactionsName fallback
brand name: atropine sulfate
generic name: ATROPINE SULFATE
AtropineATROPINE SULFATEApotex Corp.127a7e32-a150-01d6-a66a-b7708d85809f2026-03-10Warnings, Adverse reactionsName fallback
generic name: ATROPINE SULFATE
Atropine SulfateATROPINE SULFATEA-S Medication Solutions739f384f-1a69-4953-93a0-aa6a76de0ecc2026-02-18Warnings, Adverse reactionsName fallback
brand name: Atropine Sulfate
generic name: ATROPINE SULFATE
ATROPINEATROPINE SULFATEA-S Medication Solutionsb4736dbc-b7c8-4b33-b7a8-a47c5654a1272026-02-10Warnings, Adverse reactionsName fallback
generic name: ATROPINE SULFATE
Atropine SulfateATROPINE SULFATEBausch & Lomb Americas Inc.e294ce2b-6bb5-4f84-8a6d-ce2402ed926d2026-02-07Warnings, Adverse reactionsName fallback
brand name: Atropine Sulfate
generic name: ATROPINE SULFATE
AtropineATROPINE SULFATERedpharm Drug46e98d0b-3a04-7feb-e063-6394a90ac75e2025-12-27Warnings, Adverse reactionsName fallback
generic name: ATROPINE SULFATE
Atropine SulfateATROPINE SULFATERedpharm Drug301ea0f4-a1dc-ad4f-e063-6294a90acc1c2025-12-23Warnings, Adverse reactionsName fallback
brand name: Atropine Sulfate
generic name: ATROPINE SULFATE
Atropine SulfateATROPINE SULFATE INJECTIONMedefil, Inc.fbfdf718-befe-ad22-e053-6294a90a37152025-12-23Warnings, Adverse reactionsName fallback
brand name: Atropine Sulfate
Atropine SulfateATROPINE SULFATEProPharma Distribution38404931-980b-0019-e063-6394a90a933f2025-12-18Warnings, Adverse reactionsName fallback
brand name: Atropine Sulfate
generic name: ATROPINE SULFATE
Atropine SulfateATROPINE SULFATEProPharma Distribution3d5c747f-3bf7-2597-e063-6394a90a828c2025-12-18Warnings, Adverse reactionsName fallback
brand name: Atropine Sulfate
generic name: ATROPINE SULFATE
AtropineATROPINE SULFATEAmneal Pharmaceuticals NY LLCf8718be5-8fa4-4c36-a4fd-fac7c3953f5a2025-12-04Warnings, Adverse reactionsName fallback
generic name: ATROPINE SULFATE
atropine sulfateATROPINE SULFATEAmneal Pharmaceuticals LLC80a31286-a741-4440-b200-290c08925d062025-12-01Warnings, Adverse reactionsName fallback
brand name: atropine sulfate
generic name: ATROPINE SULFATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.