FDA.reportPublic FDA data

Extra Strength Acetaminophen

Manufacturer
Hi-Tech Nutraceuticals, LLC | Hi-Techn Nutraceutical, LLC
Effective date
2020-08-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:16:42

Label at a glance#

ProductExtra Strength Acetaminophen
Active ingredientACETAMINOPHEN
Label structure16 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient Drug FactsActive Ingredient Drug Facts

OTC - ASK DOCTOR SECTION

Ask a Doctor Drug FactsAsk a Doctor Drug Facts

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a Doc or Pharm Drug FactsAsk a Doc or Pharm Drug Facts

OTC - DO NOT USE SECTION

Do not UseDo not Use

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reachKeep out of reach

OTC - PREGNANCY OR BREAST FEEDING SECTION

PregnantPregnant

OTC - PURPOSE SECTION

PurposePurpose

OTC - QUESTIONS SECTION

Questions or Comments? Call 1.800.222.1888

OTC - STOP USE SECTION

Stop UseStop Use

OTC - WHEN USING SECTION

DirectionsDirections

WARNINGS SECTION

WarningsWarnings

STORAGE AND HANDLING SECTION

Other InformationOther Information

INACTIVE INGREDIENT SECTION

InactivesInactives

INDICATIONS & USAGE SECTION

UsesUses

DOSAGE & ADMINISTRATION SECTION

Uses:
■ temporarily relieves minor aches and pains due to:
■ the common cold ■ headache ■backache
■ minor pain of arthritis ■ toothache ■ muscular aches
■ premenstrual and menstrual cramps
■ temporarily reduces fever

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDPPDP

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69732-00169732-001-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Extra Strength AcetaminophenACETAMINOPHENHi-Tech Nutraceuticals, LLCa36be487-7a36-550f-e053-2a95a90a95c12026-07-06WarningsExact identifier
ndc (product): 69732-001
ae247160-28fb-d732-e053-2a95a90ad347aaa81b61-56f6-39ca-e053-2995a90abbca2020-08-30WarningsExact identifier
spl id: ae247160-28fb-d732-e053-2a95a90ad347
spl set id: aaa81b61-56f6-39ca-e053-2995a90abbca

Reported adverse events (FAERS/openFDA)#

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