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Drug Facts
Acetaminophen Tablet
FDA Label NDC 68599-4681
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Mckesson for the product Acetaminophen (NDC 68599-4681). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredient (in each tablet)
Acetaminophen 500 mg
Otc - Purpose
Purpose
Pain reliever/fever reducer
Indications & Usage
Uses
For the temporary relief of minor aches and pains associated with
- headache
- muscular aches
- minor arthritis pain
- common cold
- toothache
- menstrual cramps
For the reduction of fever.
Warnings
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
- skin reddening
- blisters
- rash
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
Otc - Stop Use
Do not use
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a
- for more than 10 days for pain unless directed by a doctor
- for more than 3 days for fever unless directed by a doctor
- liver disease
- you are taking the blood thinning drug warfarin
- symptoms do not improve
- new symptoms occur
- pain or fever persists or gets worse
- redness or swelling is present
drug contains acetaminophen, ask a doctor or pharmacist.
Ask a doctor before use if you have
Ask a doctor or pharmacist before use if
Stop using and ask a doctor if
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
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.
Dosage & Administration
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 to children under 12 years of age
Other Safety Information
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 Ingredient
Inactive ingredients
corn starch, hypromellose, maltodextrin*, microcrystalline cellulose*, polyethylene glycol, povidone*, pregelatinized starch*, sodium starch glycolate*, stearic acid, titanium dioxide*.
* may contain
Otc - Questions
Questions or comments? 1-800-777-4908
Package Label.Principal Display Panel
NDC# 68599-4681-3
McKesson
Acetaminophen Tablets 500mg
Non-Aspirin
Used to reduce fever / Temporarily relieves aches and pains
2 per Pack / 250 packs per Box
MFR# 82468
* Please review the disclaimer below.
