Otc - Active Ingredient
Active ingredient (in each tablet)
Acetaminophen 325 mg
Acetaminophen Tablet, Coated
FDA Label NDC 51662-1665
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Hf Acquisition Co Llc, Dba Healthfirst for the product Acetaminophen (NDC 51662-1665). 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, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - stop use, 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 of minor aches and pains due to:
■ headache
■ muscular aches
■ minor arthritis pain
■ backache
■ the common cold
■ toothache
■ premenstrual and menstrual cramps
■ temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
■ more than 4,000 mg 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
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.
Otc - 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
Otc - Ask Doctor
Ask a doctor before use if you have
■ liver disease
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if
■ you are taking the blood thinning drug warfarin
Otc - Stop Use
Stop using and ask a doctor if
■ pain gets worse and 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
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Dosage & Administration
Directions
■ do not use more than directed (see overdose warning)
Adults and children: (12 years and over)
■ take 2 tablets every 4 to 6 hours while symptoms last.
■ do not take more than 10 tablets in 24 hours, unless directed by a doctor
■ do not use for more than 10 days unless directed by a doctor
Children under 12 years:
■ Ask a doctor
Inactive Ingredient
corn starch, hypromellose, polyethylene glycol, povidne, pregelantinized starch, sodium starch glycolate, stearic acid, titanium dioxide
Overdosage
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 critical for adults as well as for children even if you do not notice any signs or symptoms.
Storage And Handling
■ store at room temperature 59°-86°F (15°-30°C)
■ tamper-evident sealed packets
■ do not use any opened or torn packets
How Supplied
2 in 1 packet; 1 packet in 1 pouch.
Ndc 51662-1665-2
Label (51662 1665 2)
* Please review the disclaimer below.
