FDA Label for Careall Acetaminophen
View Indications, Usage & Precautions
Careall Acetaminophen 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
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.
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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