FDA.reportPublic FDA data

Extra Strength Acetaminophen

Manufacturer
Geri-Care Pharmaceutical Corp
Effective date
2024-11-28
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:39:41

Label at a glance#

ProductExtra Strength Acetaminophen
Active ingredientACETAMINOPHEN
Label structure8 sections

Indications and uses

temporarily relieves minor aches and pains temporarily reduces fever

Dosage and administration

do not take more than directed adults and children 12 years and over: take 2 caplets every 6 hours, as needed. Do not take more than 6 caplets in 24 hours. Do not take for more than 10 days unless directed by a doctor. children under 12 years: ask a doctor

Storage and handling

store at 20⁰C-25⁰C (68⁰F-77⁰F) corn starch, povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500 mg

Purpose

OTC - PURPOSE SECTION

Pain Reliever/Fever Reducer

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves minor aches and pains
  • temporarily reduces fever

Warnings

WARNINGS SECTION

Liver warning: This product contains acetaminophen.
Severe liver damage may occur if you take:

  • more than 8 caplets (4,000 mg of acetaminophen) in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Allergy alert: acetaminophen may cause severe skin reactions.
Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

Do not use

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if you have liver disease.

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

Stop use and ask a doctor if

  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • new symptom occur
  • redness or swelling is present

These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical
help or contact a Poison Control Center right away. Quick medical
attention is critical for adults as well as for children even if you
do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed
  • adults and children 12 years and over: take 2 caplets
    every 6 hours, as needed. Do not take more than 6
    caplets in 24 hours. Do not take for more than 10 days unless directed by a doctor.
  • children under 12 years: ask a doctor

Other Information

STORAGE AND HANDLING SECTION

  • store at 20⁰C-25⁰C (68⁰F-77⁰F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Questions or comments?

OTC - QUESTIONS SECTION

1-800-540-3765

Package label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198440acetaminophen 500 MG Oral TabletPSN6
198440acetaminophen 500 MG Oral TabletSCD6
198440APAP 500 MG Oral TabletSY6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57896-222-01Extra Strength Acetaminophen100 in 1 BOTTLETABLET1006
57896-222-10Extra Strength Acetaminophen1000 in 1 BOTTLETABLET10006
57896-222-20Extra Strength Acetaminophen200 in 1 BOTTLETABLET2006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57896-222EXTRA STRENGTH ACETAMINOPHEN (ACETAMINOPHEN) TABLET [GERI-CARE PHARMACEUTICAL CORP]6Current NDC, Legacy NDC, 3 package rows20241129_7a7b6318-b7d6-31b1-e053-2991aa0abf25.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57896-222-01EA - Each57896-222365a662c-dea1-49fa-ac83-842a380b9cd412019-02-13
57896-222-10EA - Each57896-222435c04a0-3126-4242-8be2-da090bc3449712022-06-06
57896-222-20EA - Each57896-222dbde652c-eb9a-4f10-963c-391eb28fb89412022-03-09

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57896-22257896-222-01, 57896-222-10, 57896-222-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
POVIDONEFZ989GH94EIACT
SODIUM STARCH GLYCOLATE TYPE A CORNAG9B65PV6BIACT
STARCH, CORNO8232NY3SJIACT
STEARIC ACID4ELV7Z65APIACT

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
Extra Strength AcetaminophenACETAMINOPHENGeri-Care Pharmaceutical Corp7a7b6318-b7d6-31b1-e053-2991aa0abf252024-11-28WarningsExact identifier
ndc (package): 57896-222-10
ndc (package): 57896-222-01
ndc (package): 57896-222-20
ndc (product): 57896-222
ndc11 (package): 57896022220
ndc11 (package): 57896022210
ndc11 (package): 57896022201
spl id: 27fcbced-e80c-777a-e063-6394a90a8580
spl set id: 7a7b6318-b7d6-31b1-e053-2991aa0abf25

Reported adverse events (FAERS/openFDA)#

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