FDA.reportPublic FDA data

CareALL Acetaminophen

Manufacturer
New World Imports, Inc
Effective date
2025-12-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:18:52

Label at a glance#

ProductCareALL Acetaminophen Extra Strength
Active ingredientACETAMINOPHEN
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Acteminophen 500 mg

OTC - PURPOSE SECTION

Pain reliever / Fever reducer

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away.  Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.  ​

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains associated with: the common cold, headache, toothache, muscular aches, backache, minor pain from arthritis, premenstural and menstrual cramps

Temporarily reduces fever

WARNINGS SECTION

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

  • more than 4000 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 haveliver disease

Ask a doctor or pharmacist before use if youare taking the blood thinning drug warfarin

Stop use and ask a doctor if:

  • Pain gets worse or lasts for more than 10 days
  • Fever gets worse or lasts for more than 3 days
  • New symptoms occur
  • Redness or swelling is present

These could be signs of a serious condition

If pregnant of breast-feeding,ask a health professional before use.

Do not exceed recommended dosage.

DOSAGE & ADMINISTRATION SECTION

​Do not use more than directed (see overdose warnings)

Adults and children 12 years of age and older:

  • Take 2 caplets every 6 hours while symptoms last.  
  • Do not take more than 6 caplets in 24 hours, unless directed by a doctor.  ​
  • Do not use more than 10 days unless directed by a doctor.

Children under 12 years of age: consult a doctor

INACTIVE INGREDIENT SECTION

Corn Starch, povidone, pregelatinized starch, sodium starch glycolate, stearic acid

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

50024ACC Label50024ACC Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198440acetaminophen 500 MG Oral TabletPSN2
198440acetaminophen 500 MG Oral TabletSCD2
198440APAP 500 MG Oral TabletSY2

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130085317004866GTIN-13: 0085317004866
EAN-13: 0085317004866
GTIN-12: 085317004866
UPC-A: 085317004866
GTIN storage (14 digits): 00085317004866		50024ACC Label.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51824-099-01CareALL AcetaminophenExtra Strength100 in 1 BOTTLETABLET1002
51824-099-24CareALL AcetaminophenExtra Strength24 in 1 CASETABLET242

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51824-099-01EA - Each51824-099117c2a44-527f-4675-ad03-8046894b6ec412024-11-05

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
51824-09951824-099-01, 51824-099-24

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
STARCH, CORNO8232NY3SJIACT
STEARIC ACID4ELV7Z65APIACT
POVIDONEFZ989GH94EIACT
SODIUM STARCH GLYCOLATE TYPE A CORNAG9B65PV6BIACT
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
CareALL Acetaminophen Extra StrengthACETAMINOPHENNew World Imports, Inc66244cdb-2680-4fa8-890d-32aefd4900382025-12-01WarningsExact identifier
ndc (package): 51824-099-24
ndc (package): 51824-099-01
ndc (product): 51824-099
ndc11 (package): 51824009901
ndc11 (package): 51824009924
spl id: 44eb2dfc-5440-515b-e063-6294a90a6e33
spl set id: 66244cdb-2680-4fa8-890d-32aefd490038

Reported adverse events (FAERS/openFDA)#

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