FDA.reportPublic FDA data

ATROPINE SULFATE

Manufacturer
Sparhawk Laboratories, Inc.
Effective date
2017-02-01
Label type
PRESCRIPTION ANIMAL DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:20:19

Label at a glance#

ProductATROPINE SULFATE
Active ingredientATROPINE SULFATE
Label structure6 sections

Dosage and administration

Cattle:  20 mg per 100 lbs. of body weight Horses:  6.5 mg per 100 lbs. of body weight Sheep:  20 mg per 100 lbs. of body weight The recommended average initial dose should be split, injecting one quarter (1/4) to one-third (1/3) slowly I.V. and the remainder I.M. or S.C.  After symptoms appear to be under control, repeated maintenance doses should be administered at 3 to 6 hour intervals based on the individual r...

Storage and handling

Store at controlled room temperature between 15 o -30 o C (59 o -86 o )

Label contents#

Full prescribing information#

DESCRIPTION SECTION

INJECTABLE SOLUTION

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.

Each mL contains:

Atropine Sulfate .....................  15 mg
Sodium Chloride  .....................  9 mg
Benzyl Alcohol  ..........................  1%
Water for Injection  ....................  q.s.

INDICATIONS:

INDICATIONS & USAGE SECTION

For use as an antidote in the treatment of organophosphate insecticide poisoning of cattle, horses and sheep.

WARNING:

WARNINGS SECTION

Poisonous alkaloid.  Keep out of reach of children.  Antidotes: warmth, emetics, cholinergics

STORAGE AND HANDLING SECTION

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

DOSAGE AND ADMINISTRATION; INITIAL DOSE:

DOSAGE & ADMINISTRATION SECTION

Cattle:  20 mg per 100 lbs. of body weight
Horses:  6.5 mg per 100 lbs. of body weight
Sheep:  20 mg per 100 lbs. of body weight

The recommended average initial dose should be split, injecting one quarter (1/4) to one-third (1/3) slowly I.V. and the remainder I.M. or S.C.  After symptoms appear to be under control, repeated maintenance doses should be administered at 3 to 6 hour intervals based on the individual response of the animal.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Atropine Sulfate LA labelAtropine Sulfate LA label

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58005-307ATROPINE SULFATE INJECTION, SOLUTION [SPARHAWK LABORATORIES, INC.]2Unmatched20170201_3ea6a37f-2c3b-4ea1-b00a-d15b7bc293c5.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ATROPINE SULFATEACTIVE INGREDIENT03J5ZE7KA51
ATROPINEACTIVE MOIETY7C0697DR9I1

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
58005-30758005-307-04

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.