Active Ingredient (In Each Tablet)
Acetaminophen 500mg
Acetaminophen Tablet
FDA Label NDC 55289-880
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pd-rx Pharmaceuticals, Inc. for the product Acetaminophen (NDC 55289-880). 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 (in each tablet), purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, stop use and ask a doctor if:, 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
Uses
Temporarily relieves minor aches and pains due to:
- the commom cold
- headache
- backache
- minor pain of arthritis
- toothache
- muscular aches
- menstrual cramps
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
Allergy warning:Acetaminophen may cause severe skin reaction. 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 more than 10 days.
- Fever gets worse or lasts 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.
Keep Out Of Reach Of Children.
Overdose Warning:
In the case of overdose, get medical help or contact a Poison Control Center right away.(1-800-222-1222).
Directions
- do not take more than directed (see overdose warning).
- Adult and Children 12 years and over: take 2 tablets, every 4 to 6 hours while symptoms last. Do not take more than 6 tablets in 24 hours unless directed by a doctor. Do not take for more than 10 days unless directed by a doctor.
- Children under 12 years: Ask a doctor.
Inactive Ingredients
Povidone, Pregelatinized corn starch, sodium starch glycolate, stearic acid.
Questions?
Adverse drug event call: (866) 562-2756 Mon-Fri 8AM to 4PM
16 How Supplied/Storage And Handling
Acetaminophen tablets, 500mg, are available for oral administration as white, round, imprinted with PH044 .
Bottles of 24 (NDC 55289-880-24)
Bottles of 30 (NDC 55289-880-30)
Bottles of 100 (NDC 55289-880-01)
Storage Store at 20°C to 25°C (68°F to 77°F)
* Please review the disclaimer below.
