Careall Acetaminophen Tablet
FDA Label NDC 51824-061

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 51824-061). 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, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Acetaminophen 325mg

Purpose

Pain reliever / Fever reducer

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 problems.

Uses

Temporary relief of minor aches and pains associated with:

common cold, headache, toothache, muscular aches, backache, arthritis, premenstrual and menstrual cramps, and reduction of fever

Warnings

Liver warning: This product contains acetaminophen.  Severe liver damage may occur if:

Adult takes more than 4,000mg of acetaminphen in 24 hours

Child takes more than 5 doses in 24 hours

Taken with other drugs containing acetaminophen

Adult has 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 or 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 allergic to acetaminophen.

Ask a doctor before use if user has: liver disease

Ask a doctor or pharmacist before use if:the user is taking the blood thinnig drug warfarin.

Stop use and ask a doctor if: Symptoms do not improve.  Pain gets worse or lasts for more than 10 days.  Pain gets worse or lasts more than 5 days in children under 12 years.  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 or breast-feeding,ask a health professional before use. 

Overdose warning: taking more than the recommended dose (overdose) may cause liver damage.  In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.  Quick medical action is critical for adults as well as for children, even if you do not notice any signs or symptoms.
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Dosage & Administration

Adults and children 12 years of age and older:  Take 2 tablets every 4 to 6 hours as needed.  Do not take more than 10 tablets in 24 hours.

Children 6-11 years of age: Take 1 tablet every 4 to 6 hours as needed.  Do not take more than 5 tablets in 24 hours.

Children under 6 years of age: Do not use.

Inactive Ingredient

Corn starch, povidone, pregelatinized starch, sodium starch glycolate, stearic acid

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