FDA Label for Careall Acetaminophen Extra Strength

View Indications, Usage & Precautions

Careall Acetaminophen Extra Strength Product Label

The following document was submitted to the FDA by the labeler of this product New World Imports, Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient



Acteminophen 500 mg


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.