FDA Label for Careall Non Aspirin Extra Strength
View Indications, Usage & Precautions
Careall Non Aspirin 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.
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.
* Please review the disclaimer below.