CareALL Acetaminophen

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name
CareALL Acetaminophen
Generic name
ACETAMINOPHEN
Manufacturer
New World Imports, Inc
Product type
HUMAN OTC DRUG
SPL set ID
1148b4d9-fa6a-49e6-9663-17b2c8373846
SPL ID
468f56ff-a761-5ebd-e063-6394a90aa40c
Version
4
Effective date
2025-12-22
Source export date
2026-09-28
Source partition
12
Source file
https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:26:47
Harmonized routes table
Harmonized routes
ORAL

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 tablets (3,250mg) in 24 hours for adults or 5 tablets (1,625mg) in 24 hours for children. Severe liver damage may occur if: Adult takes more than 4,000mg of acetaminphen in 24 hours Child takes more than 5 doses in 24 hours, which is the maximum daily amount Taken with other drugs containing acetaminophen Adult has 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 or 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 user has: liver disease is a child with pain of arthritis Ask a doctor or pharmacist before use if: the user is taking the blood thinnig drug warfarin. Stop use and ask a doctor if: Adult's pain gets worse or lasts for more than 10 days. Child's pain gets worse or lasts more than 5 days. Fever gets worse or lasts for more than 3 days. Redness or swelling is present. New symptoms occur. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. ​

Reported adverse events (FAERS/openFDA)#

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