FDA.reportPublic FDA data

AC FAST

Manufacturer
GRIMANN SA DE CV
Effective date
2021-04-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:39:26

Label at a glance#

ProductAC FAST
Active ingredientACETAMINOPHEN
Label structure13 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

USAGEUSAGE

INDICATIONS & USAGE SECTION

INDIINDI

WARNINGS AND PRECAUTIONS SECTION

WARNWARN

PEDIATRIC USE SECTION

PRODPROD

PREGNANCY SECTION

PREPRE

CONTRAINDICATIONS SECTION

CONTRACONTRA

ADVERSE REACTIONS SECTION

ADVERADVER

OTC - PURPOSE SECTION

PURPUR

OTC - ACTIVE INGREDIENT SECTION

ACTACT

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KOOCKOOC

INACTIVE INGREDIENT SECTION

inactinact

WARNINGS SECTION

warnwarn

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FRONTFRONT

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81660-222-012023-01-30C16284748780-1f386c64a-13be-0266-e053-dadaa90a7c1abf001b70-6164-1ec9-e053-2a95a90a1274

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81660-222-01AC FAST10 U in 1 BLISTER PACKCAPSULE, COATED101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81660-222AC FAST (PARACETAMOL) CAPSULE, COATED [GRIMANN SA DE CV]1Legacy NDC, 1 package rows20210403_bf001b70-6164-1ec9-e053-2a95a90a1274.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81660-22281660-222-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
SODIUM STARCH GLYCOLATE TYPE A CORNAG9B65PV6BIACT
MAGNESIUM STEARATE70097M6I30IACT
POLYVINYL ALCOHOL/POLYVINYL ACETATE COPOLYMER (4:1; 9500 MW)2AVG41YG39IACT
ACETAMINOPHEN362O9ITL9DACTIB

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
bf001b70-6165-1ec9-e053-2a95a90a1274bf001b70-6164-1ec9-e053-2a95a90a12742021-04-02Warnings, Adverse reactionsExact identifier
spl id: bf001b70-6165-1ec9-e053-2a95a90a1274
spl set id: bf001b70-6164-1ec9-e053-2a95a90a1274

Reported adverse events (FAERS/openFDA)#

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