CAREALL Non-Aspirin PM Extra Strength

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 Non-Aspirin PM Extra Strength
Generic name
ACETAMINOPHEN, DIPHENHYDRAMINE HCL
Manufacturer
New World Imports, Inc
Product type
HUMAN OTC DRUG
SPL set ID
499b2bf8-72fb-4500-b16e-517cab09a8ae
SPL ID
46904e1e-deb2-5fb6-e063-6394a90ad022
Version
4
Effective date
2025-12-22
Source export date
2026-09-28
Source partition
8
Source file
https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/ae3816359e336a5de4f44607730a3d12ceb61ffa012a132189ceda22541b38ee/drug-label-0008-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:54:50
Harmonized routes table
Harmonized routes
ORAL

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings 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 sever 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. with any other product containing diphenhydramine, even one used on skin in children under 12 years of age if you have even had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have liver disease a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland glaucoma Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product •drowsiness will occur •do not drive a motor vehicle or operate machinery •avoid alcoholic drinks Stop use and ask a doctor if •sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness •pain gets worse or last for more than 10 days. •fever gets worse or last for more than 3 days •redness or swelling are 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.