Active Ingredient (In Each Tablet)
Acetaminophen 500mg
Acetaminophen Es
FDA Label NDC 67046-028
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Contract Pharmacy Services-pa for the product Acetaminophen Es (NDC 67046-028). 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), purpose, uses, warnings, do not use, otc - ask doctor, ask a doctor or pharmacist before use if you are, otc - stop use, 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:
- 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 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
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
Otc - Ask Doctor
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
Otc - Stop Use
Stop and ask doctor before use 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 signs of a serious condition.
Otc - Pregnancy Or Breast Feeding
If pregant or breast-feeding, ask doctor before use.
Keep Out Of Reach Of Children.
Directions
- do not take more than directed (see overdose warning).
- Adult and Children 12 years and over: take 2 tablets, every 4 to 6 hours while symptoms last. Do not take more than 8 tablets in 24 hours. Do not take for more than 10 days unless directed by a doctor.
- Children under 12 years: do not use adult extra strength product in children under 12 years of age; this will provide more than recommended dose (overdose) and may cause liver damage.
Overdose Warning:
Taking more than the recommended dose (overdose) may cause liver damage. In the case of overdose, get medical help or contact a Poison Control Center right away.
Inactive Ingredients
Povidone, Pregelatinized corn starch, sodium starch glycolate, stearic acid.
Questions?
Adverse drug event call: (866) 562-2756
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