Active Ingredient (Per Tablet)
Acetaminophen 325mg
Acetaminophen Tablet
FDA Label NDC 55289-563
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 55289-563). 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 (per 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 common 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
- 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
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 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 sign of a serious condition.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of The Reach Of Children.
Overdose Warning:
Taking more than the recommended dose (overdose) may cause liver damage. In the case of accidental overdose, get medical help or contact a Poison Control Center right away.
Directions
- do not take more than directed (see overdose warning).
| Adults and children 12 years and over
| Take 2 tablets every 4 to 6 while symptoms last.
Do not take more than 12 tablets in 24 hours. |
| Children 6 to under 12 years
| Take 1 tablet every 4 to 6 while symptoms last.
Do not take more than 5 tablets in 24 hours. |
| Children under 6 years
| Do not use adult regular strength products in childern under 6 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.
|
Other Information
- Tamper Evident: do not use if imprinted safety seal under cap is broken or missing
- store between 20-25°C (68-77°F)
- use by expiration date on package
Inactive Ingredients:
Povidone, pregelatinized starch, sodium starch glycolate, stearic acid.
Questions?
Adverse drug event call: (866) 562-2756
How Supplied
Bottles of 4, 6, 12, 20, 24, 30, 50 and 100 tablets.
Package Label.Principal Display Panel
Image (55289563)
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