Active Ingredient
Acetaminophen 325mg
Careall Acetaminophen Tablet
FDA Label NDC 51824-085
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by New World Imports, Inc for the product Careall Acetaminophen (NDC 51824-085). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, keep out of reach of children, uses, warnings, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 immediately (1-800-222-1222). Quick medical attention is critical for adults as well as for chidren even if you do not notice any signs or symptoms.
Uses
Temporary relieves minor aches and pains due to:
the common cold, headache, toothache, muscular aches, backache, minor pain of 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 or any of the inactive ingredients in this product.
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:
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.
These could be signs of a serious condition.
If pregnant or breast-feeding,ask a health professional before use.
Dosage & Administration
Adults and children 12 years of age and older:
Take 2 tablets every 4 to 6 hours while symptoms last
Do not take more than 10 tablets in 24 hours.
Do not use for more than 10 days unless directed by a doctor
Children 6-11 years of age:
Take 1 tablet every 4 to 6 hours while symptoms last.
Do not take more than 5 tablets in 24 hours.
Do not use for more than 5 days unless directed by a doctor
Children under 6 years of age: Ask a doctor
Inactive Ingredient
povidone, pregelatinized starch, sodium starch glycolate, stearic acid
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