Drug Facts-Acetaminophen
Acetaminophen 500 mg
Acetaminophen Tablet, Coated
FDA Label NDC 41226-697
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kroger Company for the product Acetaminophen (NDC 41226-697). 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 drug facts-acetaminophen, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Acetaminophen 500 mg
Otc - Purpose
Pain reliever/fever reducer
Indications & Usage
Uses
•temporarily relieves minor aches and pains due to:
•the common cold
•headache
•backache
•minor pain of arthritis
•toothache
•muscular aches
•premenstrual and menstrual cramps
•temporarily reduces fever
Warnings
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
•more than 4,000 mg of acetaminophen in 24 hours
•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.
Otc - Do Not Use
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
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
Otc - Stop Use
Stop use and ask a doctor 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 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: 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.
Dosage & Administration
Directions
- do not take more than directed (see overdose warning)
- take 2 caplets every 6 hours while symptoms last
- do not take more than 6 caplets in 24 hours, unless directed by a doctor
- do not use for more than 10 days unless directed by a doctor
- ask a doctor
adults and children 12 years and over
children under 12 years
Other Information
- store between 20-25°C (68-77°F)
Inactive Ingredient
Inactive ingredients Croscarmelose Sodium,Crospovidone,FD&C red #40 aluminium lake, FD&C yellow # 6 alluminium lake,hypromelose,Magnesium Stearate, Mica based Pearlescent pigment, polyethylene glycol 400,polyethylene glycol 6000, polysorbate 80, povidone, pregelatinized starch.
Otc - Questions
call 1-800-632-6900.
Package Label.Principal Display Panel
Acetaminophen 500 mg-24ct-carton (Aceta 24 Carton)
Acetaminophen 500 mg-24ct-bottle Label (Aceta 24 Label)
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