Drugplain

CareOne Acetaminophen 500 mg/1

Acetaminophen · TABLET · American Sales Company

No Recall HistoryCurrently in Shortage
Plain English

CareOne Acetaminophen is a tablet containing acetaminophen at 500 mg/1, taken oral. Manufactured by American Sales Company.

Key Facts

Brand Name
CareOne Acetaminophen
Generic Name
Acetaminophen
NDC Code (Product)
41520-064
Manufacturer
American Sales Company
Strength
500 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
M013
Marketing Start
07/20/2016

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

off label use22,386 reports
fatigue20,435 reports
drug ineffective18,152 reports
pain18,105 reports
nausea17,622 reports
headache16,715 reports
toxicity to various agents15,539 reports
dyspnoea14,573 reports
arthralgia14,307 reports
pyrexia14,270 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

Dosage & Administration

Directions • do not take more than directed (see overdose warning) adults and children 12 years and over • take 2 caplets at bedtime • do not take more than 2 caplets of this product in 24 hours children under 12 years do not use

Warnings

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take • more than 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 • in children under 12 years of age • 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 • if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have • liver disease • glaucoma • trouble urinating due to an enlarged prostate gland • a breathing problem such as emphysema or chronic bronchitis 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 • avoid alcoholic d

Frequently Asked Questions

What is CareOne Acetaminophen used for?

CareOne Acetaminophen contains Acetaminophen. It is a tablet taken oral. Consult your doctor for specific uses.

Is CareOne Acetaminophen a controlled substance?

CareOne Acetaminophen is not classified as a controlled substance by the DEA.

What is the generic name for CareOne Acetaminophen?

The generic name for CareOne Acetaminophen is Acetaminophen. There are 12 other brand versions of Acetaminophen.

What is the NDC code for CareOne Acetaminophen 500 mg/1?

The NDC (National Drug Code) for CareOne Acetaminophen 500 mg/1 is 41520-064, listed by American Sales Company.