Active Ingredient (In Each Tablet)
Acetaminophen 325 mg
Acetaminophen
FDA Label NDC 68071-4118
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Nucare Pharmaceuticals,inc. for the product Acetaminophen (NDC 68071-4118). 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), purposes, warnings, do not use, ask a doctor before use if the user has, ask a doctor or pharmacist before use if the user is, stop use and ask a doctor if, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purposes
Pain reliever/fever reducer
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if
- adult takes more than 12 tablets in 24 hours, which is the maximum daily amount
- child takes more than 5 doses in 24 hours
- taken with other drugs containing acetaminophen
- adult has 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.
Do Not Use
- with any other drug containing acetaminophen (prescription or non prescription). 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 The User Has
liver disease.
Ask A Doctor Or Pharmacist Before Use If The User Is
taking the blood thinning drug warfarin.
Stop Use And Ask A Doctor If
Pain gets worse or lasts more than 10 days in adults and children
Pain gets worse or lasts more than 5 days in children under 12 years
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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdose Warning:
Taking more than the recommended dose (overdose) may cause liver damage. 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.
Uses
for the temporary relief of minor aches and pains due to:
- Headache
- Muscular aches
- Backache
- Minor pain of arthritis
- The common cold
- Toothache
- Premenstrual and menstrual cramps
Temporarily reduces fever.
Directions
Do not take more than directed
| AGE | DOSE |
| Adults and Children 12 years and over |
|
| Children 6 - 11 years |
|
| Children under 6 years | Do not use adult Regular Strength products in children under 6 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage.
|
Other Information
- Do not use if imprinted Safety Seal under cap is broken or missing
- Store at room temperature
Inactive Ingredients
Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid.
Questions?
If you have any questions or comments, or to report an adverse event, please contact (800) 795-9775.
* Please review the disclaimer below.
