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
Keep out of reach of children.
Overdose warning: In case of overdose, get medical help or Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs of symptoms.
Indications & Usage
Temporary relieves minor aches and pains due to: the common cold, headache, toothache, muscular aches, backache, minor pains of arthritis, menstrual and premenstrual cramps, and temporarily reduces 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.
-if you are allergic to acetaminophen or any of the inactive ingredients in this product
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 warnings)
Adults and children 12 years of age and older: Take 2 caplets every 4 to 6 hours while symptoms last. Do not take more than 6 caplets in 24 hours. 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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