Active Ingredient
Acteminophen 500 mg
Careall Acetaminophen Tablet
FDA Label NDC 51824-060
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by New World Imports, Inc for the product Careall Acetaminophen (NDC 51824-060). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, keep out of reach of children, uses, warnings, dosage & administration, label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Pain reliever / Fever reducer
Keep Out Of Reach Of Children
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, contact a doctor or Poison Control Center (1-800-222-1222) immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Uses
Temporary relief of minor aches and pains associated with: common cold, headache, toothache, muscular aches, backache, arthritis, premenstrual and menstrual cramps, and temporarily reduces fever.
Warnings
Liver Warning:This product contains acetaminophen. Severe liver damage may occur if you take:
-Adults take more than 4,000mg 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:
-If you are allergic to Acetaminophen
-With other products containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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:
-Symptoms do not improve
-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
-A rare sensitivity reaction occurs
-You may report side effects to 1-888-952-0050
If pregnant of breast-feeding, ask a health professional before use.
Dosage & Administration
Do not use more than directed (see overdose warning) Do not use more than 10 days unless directed to do so by a doctor
Adults and children 12 years of age and older: Take 2 tablets every 4 to 6 hours as needed. Do not take more than 8 tablets in 24 hours.
Children under 12 years of age: Do not use this extra strength product. This will provide more than the recommended dose (overdose) and could cause serious health problems.
* Please review the disclaimer below.
