Careall Non Aspirin Tablet
FDA Label NDC 51824-049

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 Non Aspirin (NDC 51824-049). 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 - Active Ingredient

Acteminophen 500 mg

Otc - Purpose

Pain reliever / Fever reducer

Otc - Keep Out Of Reach Of Children

In case of accidental overdose, contact a doctor or Poison Control Center immediately.  Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.  ​Do not exceed recommended dosage.

Indications & Usage

Temporary relief of minor aches and pains associated with: common cold, headache, toothache, muscular  aches, backache, arthritis, menstrual cramps, and reduction in 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.

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.

Do not exceed recommended dosage.

Dosage & Administration

​Do not use more than directed (see overdose warnings)

Adults and children 12 years of age and older: Take 2 caplets every 4 to 6 hours as needed.  Do not take more than 8 caplets in 24 hours.  ​Do not use more than 10 days unless directed by a doctor.

Children under 12 years of age: Do not use this product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.

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