Otc - Active Ingredient
Acetaminophen 500 mg
Acetaminophen
FDA Label NDC 52959-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by H.j. Harkins Company, Inc. for the product Acetaminophen (NDC 52959-002). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, dosage & administration, inactive ingredient, otc - keep out of reach of children, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Pain Reliever/Fever Reducer
Indications & Usage
- temporarily relieves minor aches and pains
- temporarily reduces fever
Warnings
Liver warning:
This product contains acetaminophen. Severe liver damage may occur if you take
more than 8 tablets in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product
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
pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 days
new symptom 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.
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 right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Keep out of reach of children.
Dosage & Administration
- do not take more than directed
- adults and children 12 years and over: take 1-2 tablets every 4-6 hours, as needed; not more than 8 tablets in 24 hours
- children under 12 years: do not use
Inactive Ingredient
povidone, sodium starch glycolate, starch, stearic acid. May also contain: crospovidone, methylparaben and propylparaben
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN
Other Safety Information
- TAMPER EVIDENT: Do not use if imprinted seal under cap is missing or broken.
- store at 20⁰C-25⁰C (68⁰F-77⁰F)
- for institutional use only
* Please review the disclaimer below.
