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



Keep out of reach of children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).  Quick medical attention is critcal 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 due to: the 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 or any of the inactive ingredients in this product.

-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:

-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 warning)  

Adults and children 12 years of age and older:

Take 2 tablets every 6 hours while symptoms last 

Do not take more than 6 tablets 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


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