FDA.reportPublic FDA data

PrimeGuard

Manufacturer
Vetr, LLC
Effective date
2026-01-26
Label type
OTC ANIMAL DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:45:52

Label at a glance#

ProductPrimeGuard
Active ingredientOMEPRAZOLE
Label structure5 sections

Storage and handling

Store at 68°F-77°F (20-25°C). For transport, brief periods between 59°F-86°F (15-30°C) are permitted.

Label contents#

Full prescribing information#

WARNINGS AND PRECAUTIONS SECTION

Not for use in humans. Keep this and all medications out of the reach of children. In case of ingestion by humans, contact a physician. Do not use in horses intended for human consumption. PrimeGuard is intended for use in healthy horses. If you notice any signs of illness prior to or during the use of this product, consult your veterinarian for appropriate diagnosis and treatment recommendations.

INSTRUCTIONS FOR USE SECTION

The minimum recommended dosage is 1 mg/kg per day (0.45 mg/lb) or 1/4 syringe. Each syringe contains 4 individual daily doses for horses weighing 600-1200 lbs. Please refer to this dosage chart for help in determining the correct dose for your horse:

Horse WeightDose*

<600 lbs         Consult your veterinarian

600-1200 lbs   1 dose per day

>1200 lbs        2 doses, once per day

*Dosage duration: 8 or 28 days. Consult your veterinarian.

STORAGE AND HANDLING SECTION

Store at 68°F-77°F (20-25°C). For transport, brief periods between 59°F-86°F (15-30°C) are permitted.

OTC - ACTIVE INGREDIENT SECTION

Omeprazole USP 2.28g per syringe (37% omeprazole)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PrimeGuard ApplePrimeGuard Apple

PrimeGuard CinnamonPrimeGuard Cinnamon

PrimeGuard MolassesPrimeGuard Molasses

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
994510omeprazole 37 % Oral PastePSN1
2733836PrimeGuard 37 % Oral PastePSN1
2733836omeprazole 0.37 MG/MG Oral Paste [Primeguard]SBD1
994510omeprazole 0.37 MG/MG Oral PasteSCD1
994510omeprazole 37 % Oral PasteSY1
2733836Primeguard 0.37 MG/MG Oral PasteSY1
2733836PrimeGuard 37 % Oral PasteSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
OMEPRAZOLE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
873ef493-6b37-49d8-ac7f-bfca4117d2c1Product name520210607
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
86213-221-01PrimeGuard6.16 g in 1 SYRINGE, PLASTICPASTE6.161
86213-221-01PrimeGuard1 in 1 CARTONPASTE11
86213-221-02PrimeGuard6.16 g in 1 SYRINGE, PLASTICPASTE6.161
86213-221-02PrimeGuard6 in 1 CARTONPASTE61
86213-222-01PrimeGuard6.16 g in 1 SYRINGE, PLASTICPASTE6.161
86213-222-01PrimeGuard1 in 1 CARTONPASTE11
86213-222-02PrimeGuard6 in 1 CARTONPASTE61
86213-222-02PrimeGuard6.16 g in 1 SYRINGE, PLASTICPASTE6.161
86213-223-01PrimeGuard6.16 g in 1 SYRINGE, PLASTICPASTE6.161
86213-223-01PrimeGuard1 in 1 CARTONPASTE11
86213-223-02PrimeGuard6 in 1 CARTONPASTE61
86213-223-02PrimeGuard6.16 g in 1 SYRINGE, PLASTICPASTE6.161

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
86213-22186213-221-01, 86213-221-02
86213-22286213-222-01, 86213-222-02
86213-22386213-223-01, 86213-223-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
OMEPRAZOLEKG60484QX9ACTIB
GLYCERINPDC6A3C0OXIACT
SODIUM ALGINATEC269C4G2ZQIACT
SODIUM BICARBONATE8MDF5V39QOIACT
WATER059QF0KO0RIACT
OMEPRAZOLEKG60484QX9ACTIB
GLYCERINPDC6A3C0OXIACT
SODIUM ALGINATEC269C4G2ZQIACT
SODIUM BICARBONATE8MDF5V39QOIACT
WATER059QF0KO0RIACT
OMEPRAZOLEKG60484QX9ACTIB
GLYCERINPDC6A3C0OXIACT
SODIUM ALGINATEC269C4G2ZQIACT
SODIUM BICARBONATE8MDF5V39QOIACT
WATER059QF0KO0RIACT

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 14 · 280 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
omeprazoleOMEPRAZOLERite Aid Corporation28a0b4c8-3ad3-451c-a957-28aef5e3d8b52026-09-09WarningsName fallback
generic name: OMEPRAZOLE
OmeprazoleOMEPRAZOLEAmazon.com Services LLC94faa721-e925-4033-8661-d1990dfa920d2026-08-30WarningsName fallback
generic name: OMEPRAZOLE
OmeprazoleOMEPRAZOLEREMEDYREPACK INC.63b3982a-b541-4b0d-99d4-93a673e57d462026-08-28Warnings, Adverse reactionsName fallback
generic name: OMEPRAZOLE
AMAZON BASIC CARE OMEPRAZOLEOMEPRAZOLEAmazon.com Services LLC10efef7c-bdf4-36cf-e063-6394a90a8c0f2026-08-28WarningsName fallback
generic name: OMEPRAZOLE
good now omeprazoleOMEPRAZOLEGobrands, Inc0e7c4aee-2c9f-4d5c-9d47-c333bf00ba9f2026-08-19WarningsName fallback
generic name: OMEPRAZOLE
OmeprazoleOMEPRAZOLEDiscount Drug Mart, Inc4d5f30c2-775d-a1a3-e063-6394a90a07ff2026-08-12WarningsName fallback
generic name: OMEPRAZOLE
OMEPRAZOLEOMEPRAZOLEH E B4eb05eb3-be59-4132-95a8-5a8f5065d7582026-08-10WarningsName fallback
generic name: OMEPRAZOLE
OmeprazoleOMEPRAZOLEREMEDYREPACK INC.ded0df8b-1813-4595-ac2b-5499704bfd482026-08-05Warnings, Adverse reactionsName fallback
generic name: OMEPRAZOLE
OmeprazoleOMEPRAZOLEA-S Medication Solutions6ea9a6f3-b756-4cdf-b3db-f666a2c17d662026-08-04Warnings, Adverse reactionsName fallback
generic name: OMEPRAZOLE
OmeprazoleOMEPRAZOLEProficient Rx LP062800b1-790a-41c3-a8be-94143d2c7fb62026-08-01Warnings, Adverse reactionsName fallback
generic name: OMEPRAZOLE
OmeprazoleOMEPRAZOLEPD-Rx Pharmaceuticals, Inc.96104ea6-c08f-40b5-83f5-d840b317f1fd2026-07-31Warnings, Adverse reactionsName fallback
generic name: OMEPRAZOLE
OmeprazoleOMEPRAZOLEREMEDYREPACK INC.a19ce586-59b7-4c2e-9e8d-12e8f0f058e22026-07-21Warnings, Adverse reactionsName fallback
generic name: OMEPRAZOLE
OmeprazoleOMEPRAZOLEPD-Rx Pharmaceuticals, Inc.0344268f-d8e6-48d5-b1e1-f750ed1d8a522026-07-17Warnings, Adverse reactionsName fallback
generic name: OMEPRAZOLE
OmeprazoleOMEPRAZOLEP & L Development, LLC883e428a-e157-4bbf-8657-e7a93dc99e8c2026-07-14WarningsName fallback
generic name: OMEPRAZOLE
OmeprazoleOMEPRAZOLEWALMART INC. (see also Equate)d3c1ba08-680d-4e39-875c-1f1d42ae787c2026-07-13WarningsName fallback
generic name: OMEPRAZOLE
OmeprazoleOMEPRAZOLEHAWAII REPACK, INC.9359e826-5263-44fc-8dd3-9d0852fe42d62026-07-13Warnings, Adverse reactionsName fallback
generic name: OMEPRAZOLE
OmeprazoleOMEPRAZOLEBryant Ranch Prepackdcaadc8c-32d1-476f-b821-973c012b7fa72026-07-10Warnings, Adverse reactionsName fallback
generic name: OMEPRAZOLE
careone omeprazoleOMEPRAZOLEAmerican Sales Company5b88717a-e90c-4e74-ae2a-29270e14a3cc2026-07-08WarningsName fallback
generic name: OMEPRAZOLE
OmeprazoleOMEPRAZOLESt. Mary's Medical Park Pharmacy4c0cf466-f9e8-390e-e063-6294a90a2ed82026-07-02Warnings, Adverse reactionsName fallback
generic name: OMEPRAZOLE
OmeprazoleOMEPRAZOLEUnit Dose Solutions, Inc.557d4c2c-5541-3a51-e063-6394a90ad2782026-06-30Warnings, Adverse reactionsName fallback
generic name: OMEPRAZOLE

Reported adverse events (FAERS/openFDA)#

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