Active Ingredient (In Each Caplet)
Acetaminophen USP, 500mg
Acetaminophen Tablet
FDA Label NDC 69396-144
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Trifecta Pharmaceuticals Usa Llc for the product Acetaminophen (NDC 69396-144). 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 caplet), purpose, do not use, uses, warnings, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, keep out of reach of children, 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
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.
Uses
Temporarily relieves minor aches and pains due to
The Common cold
headache
Backache
minor pain of arthritis
toothache
muscular aches
premenstrual and menstrual cramps
temporarily relieves fever
Warnings
Liver warning
This product contains acetaminophen. Sever liver damage may occur if you take
- more than 4000mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
- skin reddening
- blisters
- rash
Allergy alert
Acetaminophen may cause severe skin reactions. Symptoms may include
if a skin reaction occurs stop use ad seek medical medical help right away
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.
Keep Out Of Reach Of Children
Keep out of reach of children
Directions
Do not take more than directed. See overdose warning
Adults and children 12 years and older
- Take 2 tablets every 6 hours while symptoms last
- Do not take more than 6 tablets in 24 hours unless directed by a doctor
- Do not use for more than 10 days unless directed by a doctor
- Ask a doctor
Children under 12 years of age
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 a sign of a serious condition
If Pregnant Or Breast-Feeding
Ask a health professional before use
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 children even if you do not notice symptoms.
Other Information
- Store at 20°C - 25°C (68°F - 77°F). See USP controlled room temperature
- Avoid high humidity
- See end panel for expiration date and lot number
- Tamper Evident. Do not use if imprinted safety seal under cap is broken or missing
- Important. Read the directions and warnings before use
Inactive Ingredients
hydroxypropyl methyl cellulose, polyethylene glycol, povidone K-30, Pregelatinized starch, Sodium starch glycolate, Stearic Acid
Questions Or Comments?
Call 1-888-296-9067
Distributed By:
Distributed By:
Trifecta Pharmaceuticals USA®
Ft. Lauderdale, FL. 33301 USA
1-888-296-9067
*This product is not manufactured or distributed by the Johnson & Johnson Corporation, owner of the registered trademark Tylenol®
Made in the USA
* Please review the disclaimer below.
