Active Ingredient
Acetaminophen 500 mg
Uline Acetaminophen Extra Strength Tablet, Film Coated
FDA Label NDC 69790-173
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Uline for the product Uline Acetaminophen Extra Strength (NDC 69790-173). 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, uses, liver warning:, allergy alert:, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use 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
For the temporary relief of minor aches and pains associated with
- headache
- toothache
- minor arthritis pain
- muscular aches
- common cold
- menstrual cramps
For the reduction of fever.
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 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.
Do Not Use
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug
- for more than 10 days for pain unless directed by a doctor
- for more than 3 days for fever unless directed by a doctor
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
- symptoms do not improve
- pain or fever persists or gets worse
- new symptoms occur
- redness or swelling is present
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
- do not use more than directed
Adults and children: (12 years and older)
Take 2 tablets every 4 to 6 hours as needed. Do not take more than 8 tablets in 24 hours.
Children under 12 years:
Do not give this adult strength product to children under 12 years of age;
this will provide more than the recommended dose (overdose) and may cause liver damage.
Other Information
- store at room temperature 59°-86°F (15°-30°C)
- tamper-evident sealed packets
- do not use any opened or torn packets
Inactive Ingredients
corn starch, hypromellose, maltodextrin*, microcrystalline cellulose*, polyethylene glycol, povidone*, pregelatinized starch*, sodium starch glycolate*, stearic acid, titanium dioxide*
* May contain
Questions Or Comments?
1-800-295-5510
Uline Acetaminophen Extra Strength Label
ULINE
Tamper evident sealed packets:
Do not use if packet is open or torn.
This package is for households without young children
See New Warnings Information
Acetaminophen
Pull to Open
Extra Strength
500 mg
• Pain Reliever
• Fever Reducer
50 Packets
2 tablets Each
Uline Extra Strength Acetaminophen Label
ULINE
Tamper evident sealed packets:
Do not use if packet is open or torn.
This package is for households without young children
See New Warnings Information
Acetaminophen
Pull to Open
Extra Strength
500 mg
• Pain Reliever
• Fever Reducer
50 Packets
2 tablets Each
* Please review the disclaimer below.
