Otc - Active Ingredient
Acteminophen 500 mg
Careall Acetaminophen Tablet
FDA Label NDC 51824-101
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 51824-101). 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 otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Pain reliever / Fever reducer
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdose warning: In case of overdose, get medical help or Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs of symptoms.
Indications & Usage
Temporary relieves minor aches and pains due to: the common cold, headache, toothache, muscular aches, backache, minor pains of arthritis, and menstrual and premenstrual cramps
Temporarily reduces fever.
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 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 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:
-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.
Dosage & Administration
Do not take more than directed (see overdose warnings)
Adults and children 12 years of age and older: Take 2 caplets every 4 to 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: ask a doctor
* Please review the disclaimer below.
